|
|
| Device |
massager, powered inflatable tube |
| Product Code | IRP |
| Regulation Number |
890.5650
|
|---|
| Device Class |
2
|
| Premarket Reviews |
|---|
| Manufacturer | Decision |
|---|
| AQUILO SPORTS LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BIO COMPRESSION SYSTEMS, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BREG INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CHENGDU CRYO-PUSH MEDICAL TECHNOLOGY CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CHENGDU CRYO-PUSH MEDICAL TECHNOLOGY CO.,LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| COOL SYSTEMS, INC. (DBA GAME READY) |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| DAESUNG MAREF CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
| DAESUNG MAREF CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| DIODE ART ENGINEERING DOING BUSINESS AS AIR RELAX |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| EVA MEDTEC, INC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| FIST ASSIST DEVICES, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| FOGGIARE TECHNOLOGIES LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| FOSHAN HONGFENG CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| FOSHAN HONGFENG CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| GUANGZHOU LONGEST SCIENCE & TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| HANURI DISTRIBUTION, INC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| HUIZHOU XINYI TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| JIANGSU MAXF ELECTRIC APPLIANCE CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| JKH HEALTH CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| JKH USA, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| KONLIKING TECH & DEV. LIMITED |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MANAMED, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MAXSTAR INDUSTRIAL CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MAXSTAR INDUSTRIAL CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MEDELLA HEALTH LIMITED |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MEGO AFEK |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MEGO AFEK AC LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| MENLO BRANDS LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MKS PARIS |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| NORMATEC INDUSTRIES, LP |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
| RAPID REBOOT RECOVERY PRODUCTS, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SHENZHEN DONGJILIAN ELECTRONICS CO.,LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| SHENZHEN DONGJILIAN MEDICAL TECH CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| SHENZHEN FUTURE ELECTRONIC CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SHENZHEN RUIYI BUSINESS TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SLK MEDICAL GMBH |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SUZHOU MICROPORT REHABTECH (GROUP) CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| THERABODY, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| THERAGUN, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| VIASONIX LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| WENZHOU LINGFENG ELECTRONIC TECHNOLOGY CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| WONJIN MULSAN CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| WONJIN MULSAN CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| XIAMEN EMOKA HEALTH SCIENCE & TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| XIAMEN HEALTHPAL ELECTRONIC CO.,LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| XIAMEN HIGH TOP ELECTRONIC TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| XIAMEN SENYANG CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| XIAMEN SIMO ELECTRONIC CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| XIAMEN WEIYOU INTELLIGENT TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| XIAMEN WEIYOU INTELLIGENT TECHNOLOGY CO.,LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ZENITH TECHNICAL INNOVATIONS |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
| ZHANGZHOU EASEPAL INNOVATION CO LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ZHANGZHOU EASEPAL MEDICAL SCIENCE AND TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ZHEJIANG LUYAO ELECTRONICS TECHNOLOGY CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
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