FDA 510(k) Applications for Medical Device:
Stimulator, Muscle, Powered, For Muscle Conditioning
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K182440 | A-1 Engineering |
30 Mauchly Suite A | Irvine | CA | 92618 |
| K143207 | Actegy, Ltd |
8 Queen Square, Ascot Business Park | Ascot | Sl5 9FE | |
| K210825 | Actegy, Ltd. |
Reflex, Cain Road | Bracknell | RG12 1HL | |
| K190924 | Actegy, Ltd. |
Reflex, Cain Road | Bracknell | RG12 1HL | |
| K192887 | Actegy, Ltd. |
Reflex, Cain Road | Bracknell | RG12 1HL | |
| K152480 | Actegy, Ltd. |
Reflex, Cain Road | Bracknell | RG12 1HL | |
| K141919 | AD REM TECHNOLOGY SARL |
9109 COPENHAVER DRIVE | POTOMAC | MD | 20854 |
| K151722 | AIME MEDICAL INC |
1258 WEST BAY DRIVE, SUITE F | LARGO | FL | 33770 |
| K152420 | AK BEAUTY ENTERPRISES, LLC |
436 NORTH BEDFORD DRIVE | BEVERLY HILLS | CA | 90210 |
| K093999 | ARP MANUFACTURING, INC |
4655 KIRKWOOD COURT | BOULDER | CO | 80301 |
| K201257 | Arrive Systems Inc |
113 Brakdale | New Ark | DE | 19711 |
| K220938 | Aura Wellness, LLC |
11530 Electron Drive | Louisville | KY | 40299 |
| K231318 | Beijing ADSS Development Co., Ltd. |
Room 609, F6, Building 13, | Beijing | 102600 | |
| K230024 | Beijing Sano Laser S&T Development Co., Ltd |
Room 7-201, No.1, Caida 3rd Street, Nancai Town, Shunyi | Bejing | 010-571506 | |
| K231368 | Bemer INT AG |
Austrasse 15 | Triesen | 9495 | |
| K151834 | BEMER Int. AG |
Austrasse 15 | Triesen | 9495 | |
| K210174 | Bemer INT. AG |
Austrasse 15 | Triesen | 9495 | |
| K071666 | BIO-MEDICAL RESEARCH CORP. |
PARKMORE BUSINESS PARK WEST | GALWAY | ||
| K070142 | BIO-MEDICAL RESEARCH CORP. |
PARKMORE BUSINESS PARK WEST | GALWAY | ||
| K180688 | Bio-Medical Research Ltd |
Parkmore Business Park West | Galway | H91 NHT7 | |
| K203513 | Bio-Medical Research Ltd |
Parkmore Business Park West | Galway | H91 NHT7 | |
| K151903 | BIO-MEDICAL RESEARCH LTD. |
PARKMORE BUSINESS PARK WEST | GALWAY | ||
| K161974 | Bio-Medical Research Ltd. |
Parkmore Business Park West | Galway | H91 NHT7 | |
| K030708 | BIO-MEDICAL RESEARCH, LTD. |
PARKMORE BUSINESS PARK, | WEST GALWAY | ||
| K022855 | BIO-MEDICAL RESEARCH, LTD. |
700 13TH ST. NW | WASHINGTON | DC | 20005 |
| K100556 | BIO-MEDICAL RESEARCH, LTD. |
BMR HOUSE | GALWAY | ||
| K010335 | BIO-MEDICAL RESEARCH, LTD. |
700 13TH ST. NW | WASHINGTON | DC | 20005 |
| K052969 | BIO-MEDICAL RESEARCH, LTD. |
PARKMORE BUSINESS PARK WEST | GALWAY | ||
| K100320 | BIO-MEDICAL RESEARCH, LTD. |
PARKMORE BUSINESS PARK, WEST | GALWAY | ||
| K072553 | BIO-MEDICAL RESEARCH, LTD. |
PARKMORE BUSINESS PARK WEST | GALWAY | ||
| K083164 | BIO-MEDICAL RESEARCH, LTD. |
PARKMORE BUSINESS PARK, WEST | GALWAY | ||
| K072294 | BIO-MEDICAL RESEARCH, LTD. |
PARKMORE BUSINESS PARK WEST | GALWAY | ||
| K201239 | Bios s.r.l. |
Via Guido Rossa 10/12 | Vimodrone | 20090 | |
| K200382 | BTL |
362 Elm Street | Marlborough | MA | 01752 |
| K163165 | BTL INDUSTRIES, INC |
47 Loring Drive | Framington | MA | 01702 |
| K180813 | BTL Industries, Inc. |
362 Elm Street | Marlborough | MA | 01752 |
| K190456 | BTL Industries, Inc. |
362 Elm Street | Marlborough | MA | 01752 |
| K182106 | BTL Industries, Inc. |
362 Elm Street | Marlborough | MA | 01752 |
| K181419 | Casgarum Investment, S.L. |
Calle Real, 17 B║ E | Illescas | 45200 | |
| K242787 | Changsha Anxiang Medical Technology Co., LTD |
Room 2404, Kairui Building,No. 245 Laodong West Road, | Changsha | 410007 | |
| K243511 | Changsha Anxiang Medical Technology Co., Ltd. |
9th Floor, R&D Center and Supporting Projects 101, | Changsha | 410000 | |
| K243763 | Changsha Anxiang Medical Technology Co., Ltd. |
9th Floor, R&D Center and Supporting Projects 101, No.18 | Changsha | 410000 | |
| K083140 | CHATTANOOGA GROUP |
4717 ADAMS RD. | HIXSON | TN | 37343 |
| K233070 | Chongqing Rob Linka Science And Technology Co., Ltd. |
B3-2, Liangjiang Health Science And Technology City, | Chongqing | 400700 | |
| K011880 | COMPEX S.A. |
1225 EYE STREET, N.W. | WASHINGTON | DC | 20005 |
| K111476 | CONTOUR TECHNOLOGY |
8401 73RD AVENUE NORTH | MINNEAPOLIS | MN | 55428 |
| K241601 | CPMT LASER (Canadian Pioneer Medical Technology Corporation) |
460 Garyray Drive, North York | Toronto | M9L1P8 | |
| K230261 | Creative Fitness Developments S.L. |
Alfahuir, 40 | Valencia | 46020 | |
| K170918 | DJO, LLC |
1430 Decision Street | Vista | CA | 92081 |
| K201653 | DJO, LLC |
1430 Decision Street | Vista | CA | 92081 |
| K170903 | DJO, LLC |
1430 Decision Street | Vista | CA | 92081 |
| K143551 | DJO, LLC |
1430 DECISION STREET | VISTA | CA | 92081-8553 |
| K160323 | DK ELECTRONICS, LLC |
413-B ELMWOOD AVE, | SHARON HILL | PA | 19079 |
| K061632 | DOMINO S.R.L. |
18 EUSTACE DRIVE | WEST HARTFORD | CT | 06110 |
| K183103 | Dongguan Yingfeng Metal & Plastic Products Co., Ltd |
Bianpu District, Lianhu Road, Qiaotou Town | Dongguan | 523520 | |
| K233470 | El.En. S.p.A. |
Via Baldanzese 17 | Calenzano | 50141 | |
| K081998 | ELECTRONIC WAVEFORM LABORATORY, INC. |
16168 BEACH BLVD., SUITE 232 | HUNTINGTON BEACH | CA | 92647 |
| K162744 | EVERYWAY MEDICAL INSTRUMENT CO., LTD. |
3FL., NO. 5, LANE 155, SECTION 3, | SHENKENG DIST, NEW TAIPEI CITY | 222 | |
| K243165 | EYWA srl |
Via Pietrarubbia n. 25/E | Rimini | 47922 | |
| K130723 | FAMIDOC TECHNOLOGY CO., LTD |
No.212 Yilong Road, Hexi Industrial Zone, Jinxia, | Dongguan | 523853 | |
| K192161 | Fast Fit LLC |
450 Park Avenue 31st Floor | New York | NY | 10022 |
| K134001 | FIRSTKIND LIMITED |
231 FAIRBANKS STREET | WEST BOYLSTON | MA | 01583 |
| K201131 | Firstkind Limited |
Hawk House, Peregrine Business Park | High Wycombe | HP13 7DL | |
| K133225 | FIT-PRO KFT LTD. |
144 RESEARCH DRIVE | HAMPTON | VA | 23666 |
| K202148 | Fit-Pro Ltd. |
7 Szabadsag Ter | Budapest | 1054 | |
| K091833 | GEMORE TECHNOLOGY CO., LTD. |
11 FL, NO. 29-5, SEC. 2 | TAN SHUI, TAIPEI HSIEN | 251 | |
| K102933 | GEMORE TECHNOLOGY CO., LTD. |
11 FL, NO. 29-5, SEC. 2 | TAN SHUI, TAIPEI HSIEN | 251 | |
| K102926 | GEMORE TECHNOLOGY CO., LTD. |
11 FL, NO. 29-5, SEC. 2 | TAN SHUI, TAIPEI HSIEN | 251 | |
| K093368 | GLOBAL MARKETING PARTNERS DBA GYMMAX USA |
28711 JAEGER DRIVE | LAGUNA NIGUEL | CA | 92677 |
| K182020 | Guangzhou Longest Science & Technology Co., Ltd. |
5&6f, Building B4, No.11, Kaiyuan Avenue Science City, | Guangzhou | 510530 | |
| K201845 | Guangzhou Longest Science & Technology Co., LTD. |
5 & 6f, Building B4, No. 11, Kaiyuan Avenue, Science City | Guangzhou | 510530 | |
| K202638 | Guangzhou Xinbo Electronic Co., Ltd. |
No.23 Building, The Second Phase, | Guangzhou | 511450 | |
| K231789 | Guangzhou Xinbo Electronic Co., Ltd. |
No.23 Building, The Second Phase | Guangzhou | 511450 | |
| K230711 | Guangzhou Xinbo Electronic Co., Ltd. |
No.23 Building, The Second Phase | Guangzhou | 511450 | |
| K212948 | Guangzhou Xinbo Electronic Co., Ltd. |
No.23 Building, The Second Phase, | Guangzhou | 511450 | |
| K191938 | Heat In A Click LLC. |
1975 Tigertail Blvd | Dania | FL | 33004 |
| K232181 | Hebei JT Medical Co., Ltd. |
C12 Hegu Industrial Park, Chaoyang Road, | Baoding | 072750 | |
| K192264 | Hivox Biotek Inc. |
5F., No. 123, Xinde Rd. | New Taipei City | 24158 | |
| K143737 | HIVOX BIOTEK, INC. |
5 F., NO. 123, Shingde Road | New Taipei City | 24158 | |
| K141921 | HIVOX BIOTEK, INC. |
5 F., NO. 123, Shingde Road | New Taipei City | 24158 | |
| K180279 | Home Skinovations Ltd. |
Tabor Building, Shaar Yokneam | Yoqneam Illit | 2069200 | |
| K133108 | HONG QIANG XING (SHENZHEN) ELECTRONICS LIMITED |
4F.,JINGCHENG BUILDING, XICHENG INDUSTRIAL ZONE | SHENZHEN | 518102 | |
| K121719 | HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED |
ROOM 1706, NO. 128 SONGLE RD | SHANGHAI | 201600 | |
| K201354 | Hong Qiangxing (Shen Zhen) Electronics Limited |
4F, Jingcheng Building, Xicheng Industrial Zone | Shenzhen | 518126 | |
| K212413 | I-Motion Group Global Iberica S.L. |
Calle Loeches 66.8 CP | Alcorcon | 28925 | |
| K171092 | International Trade Group, Inc. |
4663 Katie Lane | Oxford | OH | 45056 |
| K132179 | ION GENIUS INC |
1833 KALAKAUA AVE. | HONOLULU | HI | 96801 |
| K123158 | ION GENIUS INC |
7192 KALANIANAOLE HWY | HONOLULU | HI | 96821 |
| K192039 | Johari Digital Healthcare Limited |
G-582, 584 EPIP, Boranada | Jodhpur | 342008 | |
| K212866 | Johari Digital Healthcare Limited |
G-582, 584 EPIP, Boranda | Jodhpur | 342012 | |
| K062439 | JOHARI DIGITAL HEALTHCARE, LTD. |
26540 W. AGOURA ROAD | CALABASES | CA | 91302 |
| K131291 | JOHARI DIGITAL HEALTHCARE, LTD. |
5703 OBERLIN DR. | SAN DIEGO | CA | 92121 |
| K222400 | K1MED Co., Ltd. |
Rm.209, 1006, Woolim e-biz center II, | Seoul | ||
| K171035 | Katalyst Inc. |
316 Occidental Ave. | Seattle | WA | 98104 |
| K181199 | Katalyst Inc. |
316 Occidental Ave. | Seattle | WA | 98104 |
| K190966 | Katalyst Inc. |
316 Occidental Ave. | Seattle | WA | 98104 |
| K122414 | LETO ENTERPRISES INCORPORATION |
SUITE A-2706, ZHONGFANG JINGYUAN | SHENZHEN | 518100 | |
| K102295 | LETO ENTERPRISES INCORPORATION |
19/F, NAN DAO COMMERCIAL BLDG, | HONG KONG | 999077 | |
| K213748 | Lutronic Corporation |
Lutronic Center, 219, Sowon-Ro | Deogyang-Gu, Goyang-si | 410220 | |
| K211298 | Medical Cables S.L. |
Calle Ferrocarril del Puerto 18 - Oficina 3-4 | Mßlaga | 29002 | |
| K181955 | Medical Cables, S.L. |
Duque de la Victoria 6, 1 | Malaga | 29015 | |
| K182794 | Medical Currents Ltd |
8 Cuffe Lane | Dublin 2 | D02W840 | |
| K122393 | MIGA MEDICAL CO., LTD. |
#821 SAMIL PLAZA | GANGNAM-GU | 135-768 | |
| K182519 | Miha Bodytec Gmbh |
Siemensstr. 1 | Gersthofen | 86368 | |
| K201975 | Miha Bodytec Gmbh |
Siemensstr. 1 | Gersthofen | 86368 | |
| K221498 | Miha Bodytec GmbH |
Siemensstr. 1 | Gersthofen | 86368 | |
| K110057 | MJ SPECIALTY RETAIL |
77325 JOYCE WAY | ECHO | OR | 97826 |
| K222875 | Nanjing Vishee Medical Technology Co., Ltd. |
Building 9, No. 19, Ningshuang Road | Nanjing | 210012 | |
| K223797 | Neuro20 Technologies |
3802 Spectrum Blvd Suite 116E | Tampa | FL | 33626 |
| K191181 | NeuX Technologies, Inc. |
3802 Spectrum Blvd. Suite 112F | Tampa | FL | 33612 |
| K242186 | OFAN Intelligent Technology (Guangzhou) Co. Ltd. |
Floor 4rd Building F, Jintai Creation Park | Guangzhou | 510000 | |
| K233770 | Pepper Interactive Inc |
251 Little Falls Drive | Wilmington | DE | 19808-1674 |
| K200545 | Pollogen, Ltd |
6 Kaufman Street | Tel Aviv | 6801298 | |
| K232982 | Shandong Huamei Technology Co.,Ltd. |
Shandong Huamei Technology Co.,Ltd. | Wei Fang | 261205 | |
| K232409 | Shanghai Apolo Medical Technology Co., Ltd. |
Building 11, Lane 1566, Nanle Road, Songjiang District | Shanghai | 201613 | |
| K133965 | SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
No. 3 Building XiliBaimang Xusheng Industrial Estate | SHENZHEN | 518108 | |
| K233035 | Shenzhen Hengbosi Industrial Co., Ltd. |
1035 Chuangke Building, No.72-6 Huanguan South Road, | Shenzhen | 518000 | |
| K231136 | Shenzhen KeLuTongDa Industrial Co.,Ltd. |
217,44-46 Xintun South Road,Xinlian community,Longcheng | Shenzhen | 518172 | |
| K181728 | Shenzhen Kentro Medical Electronics Co., Ltd |
No.3, Xihu Industry Zone, Xikeng Village, Henggang Town, | Shenzhen | 518115 | |
| K211942 | Shenzhen OSTO Technology Company Limited |
No.43 Longfeng Road, Xinsheng Community, Longgang Street, | Shenzhen | 518116 | |
| K172876 | Smartmissimo Technologies Pte Ltd |
#28-01, SGX Centre II, 4 Shenton Way | Singapore | 068807 | |
| K150078 | Smartmissimo Technologies Pte Ltd |
#28-01, SGX Centre II, 4 Shenton Way | Singapore | 068807 | |
| K251746 | Sofwave Medical Ltd. |
1 Ha-Otsma St. | Yokneam Ilit | 2069200 | |
| K241685 | Sofwave Medical Ltd. |
1 Ha-Otsma St. | Yokneam Ilit | 2069200 | |
| K250146 | Sofwave Medical Ltd. |
1 Ha-Otsma St. | Yokneam Ilit | 2069200 | |
| K091865 | SPORT-ELEC |
141 RESEARCH DRIVE | HAMPTON | VA | 23666 |
| K092142 | SPORT-ELEC |
141 RESEARCH DRIVE | HAMPTON | VA | 23666 |
| K092476 | SPORT-ELEC |
141 RESEARCH DRIVE | HAMPTON | VA | 23666 |
| K081026 | SPORT-ELEC S.A. |
144 RESEARCH DRIVE | HAMPTON | VA | 23666 |
| K061914 | SPORT-ELEC S.A. |
ROUTE DE POUEN BP 35 | BOURGTHEROULDE INFREVILLE | 91400 | |
| K020427 | THE DEZAC GROUP |
719 A ST. NE | WASHINGTON | DC | |
| K020429 | THE DEZAC GROUP |
719 A ST. NE | WASHINGTON | DC | |
| K143059 | TONE-A-MATIC INTERNATIONAL INC. |
145 TRADERS BLVD EAST, UNIT 18 | MISSISSAUGA | L4Z-3L3 | |
| K183454 | Tyece Ltd. |
Unit 801, Block A, Po Lung Centre, 11 Wang Chiu Rd. | Kowloon, Hong Kong | ||
| K172241 | Tyece Ltd. |
Unit 801, Block A, Po Lung Centre, 11 Wang Chiu Rd., | Kowloon | ||
| K031611 | VALMED CORP. |
5080 NORTH OCEAN DRIVE 1A | SINGER ISLAND | FL | 33404 |
| K222386 | VB Technologies AG |
Baarerstrasse 12 | Zug | 6300 | |
| K202653 | Well Brain International Ltd. |
Room 1403 Fook Yip Building, 53-57 Kwai Fung Crescent, | Hong Kong | ||
| K142055 | WELL BRAIN INTERNATIONAL, LTD. |
ROOM 03, 14/F, FOOK YIP BLG., 53-57 | KWAI CHUNG, N.T. | ||
| K130074 | WELL BRAIN INTERNATIONAL, LTD. |
RM.1212, 12 FL, HARBOUR CRYSTAL CENTRE, NO. 100 GRANVILLE RD | HONG KONG | 999077 | |
| K111781 | WELL BRAIN INTERNATIONAL, LTD. |
100 GRANVILLE ROAD | HONG KONG, SAR CHINA | CH | |
| K123075 | WELL-LIFE HEALTHCARE LIMITED |
1FL, NO.16, LANE 454 | YUNGHE CITY, TAIPEI COUNTY | CH | |
| K072168 | WELL-LIFE HEALTHCARE LIMITED |
1FL, NO.16, LANE 454 | YUNGHE CITY, TAIPEI COUNTY | ||
| K102786 | WELL-LIFE HEALTHCARE LIMITED |
1FL, NO.16, LANE 454 | YUNGHE CITY, TAIPEI COUNTY | 234 | |
| K221200 | XBody Hungary Kft. |
Gy÷rgy Aladßr u. 35-39 | Budapest | 1125 | |
| K242926 | XBody Hungary Kft. |
Gy÷rgy Aladßr u. 35-39. | Budapest | 1125 | |
| K190038 | XBody Hungary Kft. |
Gyorgy Aladar u. 35-39 | Budapest | 1125 | |
| K233492 | Xiamen Comfier Technology Co., Ltd |
2/F,3/F,4/F,5/F, No.65 Sunban South Road, Jimei District | Xiamen | 361012 | |
| K250038 | Zhengzhou PZ Laser Slim Technology Co., Ltd. |
Room 201, 2nd Floor, Building 2, No. 52 Hongsong Road, | Zhengzhou | 450001 | |
| K251378 | Zimmer MedizinSysteme GmbH |
Junkersstrasse 9 | Neu-Elm | 89231 | |
| K220601 | Zimmer MedizinSysteme GmbH |
Junkersstrasse 9 | Neu-Ulm | 89231 | |
| K192940 | Zimmer MedizinSysteme GmbH |
Junkerstrasse 9 | Neu-Ulm | 89231 | |
| K182963 | Zimmer MedizinSysteme GmbH |
Junkersstrasse 9 | Neu-Ulm | 89231 | |
| K240347 | Zimmer MedizinSysteme GmbH |
Junkerstrasse 9 | Neu-Ulm | 89231 |
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