|
Device |
stimulator, nerve, transcutaneous, over-the-counter |
Definition |
TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES |
Product Code | NUH |
Regulation Number |
882.5890
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ACUMED MEDICAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AEMED, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANDON HEALTH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANDON HEALTH CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANHUI JINJIANQIAO MED-TECH CO,. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AVAZZIA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BAYER HEALTHCARE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BAYER HEALTHCARE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BEWELL CONNECT CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMEDICAL LIFE SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CHANGSHA YUWEN MEDICAL EQUIPMENT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CHANGSHA YUWEN MEDICAL EQUIPMENT CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHATTEM, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHONGQING ROB LINKA SCIENCE AND TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DONGGUAN BOHUIKANG TECHNOLOGY CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EASYMED INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EASYMED INSTRUMENTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EASYWELL BIOMEDICALS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENDURANCE THERAPEUTICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EVERYWAY MEDICAL INSTRUMENTS CO., LDT. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EVERYWAY MEDICAL INSTRUMENTS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
FAMIDOC TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUJI DYNAMICS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GEMORE TECHNOLOGY CO LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GEMORE TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANDONG SKG INTELLIGENT TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGZHOU HUA KAI ELECTRONIC TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGZHOU LONGEST SCIENCE & TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGZHOU XINBO ELECTRONIC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GURIN PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GYMMAX TECHNOLOGY SHENZEN CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HB MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEALTHCARE INNOVATIONS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEALTHMATE INTERNATIONAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEAT IN A CLICK LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HI-DOW INTERNATIONAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HI-DOW INTERNATIONAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HINGE HEALTH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HIVOX BIOTEK INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
HIVOX BIOTEK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HOLLYWOG LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOLLYWOG, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HONG KONG ETECH GROUPS LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
INTERNATIONAL TRADE GROUP, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IQ TECHNOLOGIES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
JIANGXI ROYALL SMART TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JKH HEALTH CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JKH HEALTH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JKH HEALTH CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JKH USA, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
LASER HEALTH TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIFECARE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
M.I.TECH CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MANAMED, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MARC PRO |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MARCHAN MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDECELL US, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIRUNE CO, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICRO CURRENT TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MID-AMERICA MEDICAL INNOVATIONS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MINGHUANGDA ELECTRONIC CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEUROMETRIX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NEWMARK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
NINGBO MEDKINETIC MEDICAL DEVICE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NU-BECA & MAXCELLENT CO. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OMRON HEALTHCARE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
ORIENTAL INSPIRATION LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PDI WORKS, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PFIZER INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS CONSUMER LIFESTYLE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PINOOK USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PIXIE CUP LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PLAYMAKAR INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PLEXUS YOGA LLC DBA CHIRP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
POURANG BRAL, DDS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRIZM MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PROSPERA CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SAVIA LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SELF DOCTOR CARE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN AS TEC TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN AS-TEC TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN DONGDIXIN TECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN DONGJILIAN ELECTRONICS CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN EAPPLY TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN FUTURE ELECTRONIC CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN IMDK MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN JIANFENG ELECTRONIC TECHNOLOGY CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN JIANFENG ELECTRONIC TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN JINGKEHUI ELECTRONIC CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN LEADING PERFECTION TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN LEQING MEDICAL INSTRUMENT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN MINGHUANGDA ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN OSTO TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SHENZHEN ROUNDWHALE TECHNOLOGY CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN ROUNDWHALE TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN YICAI HEALTH TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN YIRAN INTELLIGENT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN YUEHUA XINSEN TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMARTMEDICALDEVICE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUNMAS (H.K.) TRADING LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TENSCARE LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TENSCARE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THIMBLE BIOELECTRONICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TIMEWAVER PRODUCTION GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOHKAI PRECISION ELECTRICAL MANUFACTORY (SHENZHEN) LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOP-RANK HEALTH CARE CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRIOWAVE TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TYECE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TYECE LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WELL-LIFE HEALTHCARE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZMI ELECRONICS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|