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 |
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 |
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 |
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 |
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 |
K221862 |
Huizhou XINYI Technology Co., LTD. |
Area (Building 3), Changbu Village
| Huizhou |
|
516200 |
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 |
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 |
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 |
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 |
K222924 |
Shenzhen Ruiyi Business Technology Co., Ltd. |
Qianhai Complex A201, Qianwan Road 1, Qianhai, Shenzhen-Hong
| Shenzhen |
|
518000 |
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 |
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 |
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 |
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 |
K222949 |
Zhejiang Luyao Electronics Technology Co., Ltd |
Wei 1st Road, Mechanical Park,
| Wenzhou |
|
325409 |
|
|