FDA 510(k) Applications for Medical Device:
Massager, Powered Inflatable Tube
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K000655 | AHAVA STEIN |
P.O.B. 454 | GINOT SHOMRON, 44853 | ||
| K223164 | Aquilo SPorts LLC |
1902 Campus Pl Ste 12 | Louisville | KY | 40299 |
| K243572 | Avanos Medical, Inc. |
5405 Windward Parkway | Alpharetta | GA | 30004 |
| K122112 | BIO COMPRESSION SYSTEMS, INC. |
1983 Hazelwood Road | TOMS RIVER | NJ | 08754 |
| K961426 | BIO COMPRESSION SYSTEMS, INC. |
P.O. BOX 470218 | BROADVIEW HEIGHTS | OH | 44147 |
| K213533 | Bio Compression Systems, Inc. |
120 West Commercial Ave | Moonachie | NJ | 07074 |
| K183702 | Breg Inc. |
2885 Locker Ave. East | Carlsbad | CA | 92010 |
| K222669 | Chengdu Cryo-Push Medical Technology Co., Ltd |
102, 105, Zone 20, Huayin Industrial Port, No. 618 | Chengdu | 611137 | |
| K230524 | Chengdu Cryo-Push Medical Technology Co.,Ltd |
102, 105, Zone 20, Huayin Industrial Port, No.618, Kexing | Chengdu | 611137 | |
| K192114 | Cool Systems, Inc. (dba Game Ready) |
1800 Sutter Street, Suite 500 | Concord | CA | 94520 |
| K171685 | Cool Systems, Inc. (dba Game Ready) |
1800 Sutter Street, Suite 500 | Concord | CA | 94520 |
| K072620 | COOLSYSTEMS, INC. |
2201 DWIGHT WAY | BERKELEY | CA | 94704 |
| K071050 | COOLSYSTEMS, INC. |
2201 DWIGHT WAY | BERKELEY | CA | 94704 |
| K203019 | DaeSung Maref Co., Ltd |
298-24, Gongdan-ro | Gunpo-si | 15809 | |
| K231437 | Daesung Maref Co., Ltd |
298-24, Gongdan-ro | Gunpo-Si | 15809 | |
| K160178 | DaeSung Maref Co., Ltd |
298-24, Gongdan-ro | Gunpo-si | 15809 | |
| K202395 | DaeSung Maref Co., Ltd |
298-24, Gongdan-ro | Gunpo-si | 15809 | |
| K150033 | DAESUNG MAREF CO., LTD. |
298-24, GONGDAN-RO | GUNPO-SHI | 435-862 | |
| K112441 | DAESUNG MAREF CO., LTD. |
4568 WEST 1ST STREET | LOS ANGELES | CA | 90004 |
| K102320 | DAESUNG MAREF CO., LTD. |
49 CANDLEWOOD WAY | BUENA PARK | CA | 90621 |
| K203498 | Daesung Maref CO., LTD. |
298-24, Gongdan-Ro | Gunpo-Si | 15809 | |
| K211460 | Diode Art Engineering doing business as Air Relax |
9535 Brasher St | Pico Rivera | CA | 90660 |
| K212491 | Diode Art Engineering doing business as Air Relax |
9535 Brasher St | Pico Rivera | CA | 90660 |
| K991921 | EISCHOCO, INC. |
1232 S.E. 282ND AVE. | GRESHAM | OR | 97080 |
| K964957 | EISCHOCO, INC. |
1232 S.E. 282ND AVE. | GRESHAM | OR | 97080 |
| K243177 | ElastiMed Ltd. |
HaKidma St. 7 | Yokne'am Illit | 2069236 | |
| K202693 | Eva Medtec, Inc |
6300 W. Old Shakopee Road, Suite 140 | Bloomington | MN | 55438 |
| K122154 | FIG, LLC |
2839 HARVEST MOON DRIVE | ORANGE PARK | FL | 32073 |
| K210281 | Fist Assist Devices, LLC |
25599 Fernhill Road | Los Altos | CA | 94024 |
| K201730 | Foggiare Technologies LLC |
1920 West Bay Drive, Suite 4 | Largo | FL | 33770 |
| K201982 | Foshan Hongfeng Co., Ltd |
No.4-2 Leqiang Road, Leping Sanshui | Foshan | 528000 | |
| K212169 | Foshan Hongfeng Co., Ltd. |
No.4-2 Leqiang Road, Leping Sanshui | Foshan | 528000 | |
| K974395 | GRAD-LINE CORP. |
762 SOUTH FEDERAL HIGHWAY | DEERFIELD | FL | 33441 |
| K250244 | Guangzhou Longest Medical Technology Co., Ltd. |
301 of Building 1, No.96, Chuangqiang Road, Ningxi Street | Guanzhou | 511399 | |
| K191862 | Guangzhou Longest Science & Technology Co., Ltd. |
5&6f, Building B4, No.11, Kaiyuan Avenue, Science City | Guangzhou | 510530 | |
| K202044 | Hanuri Distribution, Inc |
9601 Owensmouth Ave. # 8 | Chatsworth | CA | 91311 |
| K240981 | Huizhou XINYI Technology Co., Ltd. |
Area(Building 3), Changbu Village, Xinwei, Huiyang District, | Huizhou | 516223 | |
| K221862 | Huizhou XINYI Technology Co., LTD. |
Area (Building 3), Changbu Village | Huizhou | 516200 | |
| K242140 | Jiale Health Technology Shenzhen Co., Ltd. |
201, Builing A, No, 17, Guangjin Road, Shapu Community, | Shenzhen | 518000 | |
| K230500 | Jiangsu MaxF Electric Appliance Co., Ltd |
NO.12, West Park Road, Rulin Town | Changzhou | 213200 | |
| K240986 | JKH Health Co., Ltd. |
4-5F, Building 12, Hengmingzhu Industrial Park | Shenzhen | 518104 | |
| K223541 | JKH Health Co., Ltd. |
4-5F, Building 12, Hengmingzhu Industrial Park, | Shenzhen | 518104 | |
| K201645 | JKH USA, LLC |
20505 Valley Blvd. Suite 108 | Walnut | CA | 91789 |
| K210240 | Konliking Tech & Dev. Limited |
The 2nd Floor, Building D, No 168, Hengping Road, Longgang | Shenzhen | 518115 | |
| K200351 | ManaMed, Inc. |
5240 W. Charleston Blvd | Las Vegas | NV | 89146 |
| K130385 | MAXSTAR INDUSTRIAL CO. LTD. |
4568 W. 1ST STREET, STE 104 | LOS ANGELES | CA | 90004 |
| K173158 | Maxstar Industrial Co., Ltd |
152 - 12 Hwanggeum-ro 23beon-gil, Yangchon-eup | Gimpo | 415843 | |
| K191441 | Maxstar Industrial Co., Ltd. |
152 - 12 Hwanggeum-ro 23beon-gil, Yangchon-eup | Gimpo | 415843 | |
| K223729 | Medella Health Limited |
Flat 7, 144 Third Avenue | Tauranga | 3110 | |
| K994057 | MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD. |
117 AHUZAH ST. | RA'ANANNA 43373 | 43373 | |
| K230385 | Mego Afek |
Kibbuts Afek | Kibbuts Afek | 3004200 | |
| K112479 | MEGO AFEK AC LTD |
1050 CONNECTICUT AVENUE, NW. | WASHINGTON | DC | 20036 |
| K140519 | MEGO AFEK AC LTD |
KIBBUTZ AFEK | AFEK | 30042 | |
| K150269 | Mego Afek AC Ltd. |
Kibbutz Afek | Kibbutz Afek | 3004200 | |
| K190015 | Mego Afek AC Ltd. |
Kibbutz Afek | Kibbutz Afek | 3004200 | |
| K190493 | Mego Afek AC Ltd. |
Kibbutz Afek | Kibbutz Afek | 3004200 | |
| K163280 | Mego Afek AC Ltd. |
Kibbutz Afek | Kibbutz Afek | 3004200 | |
| K192252 | Menlo Brands LLC |
2045 Avy Avenue | Menlo Park | CA | 94025 |
| K193079 | mks paris |
Zone Ecoparc 27 Rue Meziere | Fabregues | 34690 | |
| K143197 | NICE RECOVERY SYSTEMS, LLC |
1382 KALMIA AVE, | BOULDER | CO | 80304 |
| K071596 | NIHON SEIMITSU SOKKI CO., LTD. |
3F, 2-17-6 AKEBONO-CHO | TACHIKAWA- SHI | 190-0012 | |
| K220217 | NormaTec Industries, LP |
480 Pleasant Street, Suite A200 | Watertown | MA | 02472 |
| K240122 | NormaTec Industries, LP |
480 Pleasant Street, Suite A200 | Watertown | MA | 02472 |
| K221666 | NormaTec Industries, LP |
480 Pleasant Street, Suite A200 | Watertown | MA | 02472 |
| K112890 | NORMATEC INDUSTRIES, LP |
555 THIRTEENTH STREET, NW | WASHINGTON | DC | 20016 |
| K160608 | NORMATEC INDUSTRIES, LP |
44 GLEN AVE | Newton | MA | 02459 |
| K183169 | NormaTec Industries, LP |
480 Pleasant St, Suite A200 | Watertown | MA | 02472 |
| K133483 | PORTABLE THERAPEUTIX |
2001 HONOR AVE. | ASHLAND | MA | 01721 |
| K123829 | PORTABLE THERAPEUTIX, LLC |
200 HOMER AVE. | ASHLAND | MA | 01721 |
| K003909 | PROACT CO. |
PO BOX 1026 | MT PLEASANT | SC | 29465-1026 |
| K203552 | Rapid Reboot Recovery Products, LLC |
1396 W 200 S, Building 2, Unit A | Lindon | UT | 84042 |
| K182668 | Rapid Reboot Recovery Products, LLC |
1396 W 200 S Bldg 2A | Lindon | UT | 84042 |
| K030437 | SALTON, INC. |
1050 CONNECTICUT AVE., NW | WASHINGTON | DC | 20036-5339 |
| K193354 | Shenzhen Dongjilian Electronics Co.,Ltd. |
B1/1-5F, Tonglu Industrial Area, Tongxin Community | Shenzhen | 518116 | |
| K201694 | Shenzhen Dongjilian Electronics Co.,Ltd. |
B1/1-5F, Tonglu Industrial Area, Tongxin Community | Shenzhen | 518116 | |
| K222206 | Shenzhen Dongjilian Medical Tech Co., Ltd. |
B1/15F, Tonglu Industrial Area, Tongxin Community, | Shenzhen | 518116 | |
| K233536 | Shenzhen Dongjilian Medical Tech Co., Ltd. |
B1/1-5F, Tonglu Industrial Area, Tongxin Community, | Shenzhen | 518116 | |
| K213745 | Shenzhen Future Electronic Co., Ltd |
Bldg B. Qiangchengda Industrial Park, No. 30, Youtian Road, | Shenzhen | 518116 | |
| K192466 | Shenzhen Lifotronic Technology Co., Ltd. |
Unit A, 4th Floor, Building 15, No.1008 Songbai Road | ShenZhen | 518055 | |
| K232965 | Shenzhen Ruiyi Business Technology Co., Ltd. |
Qianhai Complex A201, Qianwan Road 1, | Shenzhen | 518000 | |
| K222924 | Shenzhen Ruiyi Business Technology Co., Ltd. |
Qianhai Complex A201, Qianwan Road 1, Qianhai, Shenzhen-Hong | Shenzhen | 518000 | |
| K250046 | Shenzhen Urion Technology Co., Ltd. |
Fl 4-6th of Bldg D, Jiale Science & Technology Indust Zn,No3 | Shenzhen | 518106 | |
| K242940 | SHENZHEN XINRUN ELECTRIC APPLIANCES CO LTD |
Wanan Rd, Changxing Technology Park, No13, RM 401, RM 501 | Shenzhen | 518104 | |
| K241446 | Sichuan QianIi-beoka Medical TechnoIogy lnc. |
Longtan lndustrial Park 2nd Sec,east 3rd ring road, | Chengdu | ||
| K243206 | Sichuan Qianli-beoka Medical Technology Inc. |
Longtan Industrial Park 2nd Sec, East 3rd Ring Road | Chengdu | 610052 | |
| K210913 | SLK Medical GmbH |
Am Herdicksbach 18 | Waltrop | 45731 | |
| K222136 | Suzhou MicroPort RehabTech (Group) Co., Ltd. |
No.112 Fangzhong Rd, Suzhou Industrial Park | Suzhou | 215002 | |
| K013061 | TACTILE SYSTEMS TECHNOLOGY INC |
1074 LEGION ST. | SHAKOPEE | MN | 55379 |
| K032505 | TELEBRANDS CORP |
1776 K STREET, N.W. SUITE 800 | WASHINGTON | DC | 20006-2365 |
| K092435 | THE AMERICAN EXPORT GROUP & INTERNATIONAL SERVICES |
1131 ANTHEM VIEW LANE | KNOXVILLE | TN | 37922 |
| K241256 | Therabody, Inc. |
1640 S Sepulveda Blvd | Los Angeles | CA | 90025 |
| K211745 | Theragun, Inc. |
6100 Wilshire Blvd, Suite 200 | Los Angeles | CA | 90048 |
| K040905 | TOHKAI PRECISION IND. LTD. |
2840 SCHERER DRIVE NORTH | SAINT PETERSBURG | FL | 33716 |
| K192607 | Viasonix Ltd. |
10 Hamelacha Street | Raananna | 4366105 | |
| K213000 | Wenzhou Lingfeng Electronic Technology Co., Ltd |
No.9,Jintang Road,Jielu Industry District,Bishan Town | Ruian | 325200 | |
| K120166 | WON INDUSTRIAL CO. |
4568 W. 1ST, STE 104 | LOS ANGELES | CA | 90004 |
| K102319 | WON INDUSTRIAL CO. |
49 CANDLEWOOD WAY | BUENA PARK | CA | 90621 |
| K200660 | Wonjin Mulsan Co., Ltd |
Seo-gu | Incheon | 22653 | |
| K211283 | Wonjin Mulsan Co., Ltd. |
89, Geomdan-ro, Seo-gu | Incheon | 22653 | |
| K080134 | WONJIN MULSAN CO., LTD. |
155 FLEMINGTON COURT | LA MIRADA | CA | 90638 |
| K100656 | WONJIN MULSAN CO., LTD. |
49 CANDLEWOOD WAY | BUENA PARK | CA | 90621 |
| K113275 | WONJINMULSAN CO., LTD. |
D-524 MIGUN TECHNO WORLD 2 | DAEJEON | KS | |
| K222991 | Xiamen Emoka Health Science & Technology Co., Ltd. |
D Building, No.100, Jinfu Road, Chengnan Industrial Zone | Xiamen | 361000 | |
| K211850 | Xiamen Healthpal Electronic Co.,Ltd |
No.170 Siming Park Tongan District, Xiamen City, | Xiamen | 361100 | |
| K212713 | Xiamen High Top Electronic Technology Co., Ltd. |
F2-5 No. 118 Siming Park, Tong'an Industrial Zone | Xiamen | 361000 | |
| K161907 | XIAMEN SENYANG CO., LTD. |
4-5 FLOOR, XINGBEI INDUSTRY, NO 95-99, WEST 2 ROAD, | XINGLIN XIAMEN | 361000 | |
| K181409 | Xiamen Senyang Co., Ltd. |
4-5 Floor, Xingbei Industry, No 95-99, West 2 Road | Xinglin Xiamen | 361000 | |
| K192358 | Xiamen Senyang Co., Ltd. |
4-5 Floor, Xingbei Industry, No 95-99, West 2 Road | Xinglin Xiamen | 361000 | |
| K212935 | Xiamen Simo Electronic Co., Ltd |
Floor 3rd-5th, No. 173 Siming Park, | Xia Men | 361100 | |
| K242615 | Xiamen Taotao Technology Co.,Ltd. |
Unit 1309, No. 120, Xinyuan Road, Haicang District | Xiamen City | 361000 | |
| K233238 | Xiamen Weiyou Intelligent Technology Co., Ltd. |
Unit 101-401, No.6 Xianghong Road, Xiang'an District | Xiamen | 361100 | |
| K210967 | Xiamen Weiyou Intelligent Technology Co., Ltd. |
Unit 101-401, No.6 Xianghong Road, Xiang'an District | Xiamen | 361021 | |
| K201935 | Xiamen Weiyou Intelligent Technology Co.,Ltd |
Unit 101-401, No.6 Xianghong Road, Xiang'an District | Xiamen | 361021 | |
| K243791 | Xiamen WeiYou Intelligent Technology Co.,Ltd. |
Unit 101-401,No.6 Xianghong Road,Xiang'an District | Xiamen | 361021 | |
| K243320 | Xiamen WeiYou Intelligent Technology Co.,Ltd. |
Unit 101-401,No.6 Xianghong Road,Xiang'an District | Xiamen | 361021 | |
| K242754 | ZAMAR Medical d.o.o. |
Sv Martin 6 | Vrsar | 52450 | |
| K190854 | Zenith Technical Innovations |
1396 St. Paul Ave. | Gurnee | IL | 60031 |
| K193550 | Zenith Technical Innovations |
1396 St. Paul Ave. | Gurnee | IL | 60031 |
| K231912 | Zenith Technical Innovations |
1396 St. Paul Ave. | Gurnee | IL | 60031 |
| K181149 | Zenith Technical Innovations |
1396 St. Paul Ave | Gurnee | IL | 60031 |
| K223464 | Zhangzhou Easepal Innovation Co Ltd. |
No.36 Longkun Road, Hongjian Village, Jiaomei Town, | Zhangzhou | 363000 | |
| K240373 | Zhangzhou Easepal Medical Science And Technology Co., Ltd. |
West of the 4th Floor, No. 7 Building, Easepal Factory, | Zhangzhou | ||
| K222949 | Zhejiang Luyao Electronics Technology Co., Ltd |
Wei 1st Road, Mechanical Park, | Wenzhou | 325409 |
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