Stimulator, Nerve, Transcutaneous, Over-The-Counter
Regulation 882.5890
10510(k)s in 12 months (231 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in NUH
| Company | 510(k)s | Recalls |
|---|---|---|
| Everyway Medical Instruments Co.,Ltd | 14 | 0 |
| Hivox Biotek, Inc. | 11 | 0 |
| Well-Life Healthcare Limited | 11 | 0 |
| Shenzhen Osto Technology Co., Ltd. | 10 | 0 |
| Shenzhen Kentro Medical Electronics Co., Ltd. | 9 | 0 |
| Omron Healthcare, Inc. | 7 | 0 |
| Hong Qiangxing (Shenzhen) Electronics Limited | 6 | 0 |
| Shenzhen Dongdixin Technology Co., Ltd. | 6 | 0 |
| Changsha Yuwen Medical Equipment Co., Ltd. | 4 | 0 |
| Counter Scientific Development (Gz), Ltd. | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 12, 2013 | K122410 | I RUNE (I-200L) Medirune Co, Ltd., KR | NUH |
| Sep 26, 2013 | K130150 | TCM MASSAGER Anhui Jinjianqiao Med-Tech Co,. , Ltd., CN | NUH |
| Sep 16, 2013 | K130802 | OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060) Shenzhen Dongdixin Technology Co., Ltd., CN | NUH |
| Sep 13, 2013 | K123866 | TANYX Medecell Us, Inc. | NUH |
| Jul 25, 2013 | K131159 | SMARTRELIEF Chattem, Inc. | NUH |
| Jul 19, 2013 | K124055 | T1040 AKA AURAWAVE Endurance Therapeutics, CA | NUH |
| Apr 16, 2013 | K130114 | PAINMASTER MCT PATCH Newmark, Inc. | NUH |
| Mar 28, 2013 | K122744 | PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER Prospera Corporation | NUH |
| Nov 20, 2012 | K121757 | HEALTHMATEFOREVER Healthmate International, LLC | NUH |
| Sep 7, 2012 | K121353 | MINI PATCH Well-Life Healthcare Limited, TW | NUH |
| Sep 4, 2012 | K113321 | TENS BACK PAIN RELIEF SYSTEM Savia Limited | NUH |
| Aug 20, 2012 | K120500 | THE PAIN PILOT (A.K.A PAIN PILOT) Hollywog, LLC | NUH |
| Mar 19, 2012 | K112392 | HIVOX BIOTEK INC. Hivox Biotek, Inc., TW | NUH |
| Mar 1, 2012 | K113037 | PAIN-AID Pdi Works, LLC | NUH |
| Dec 8, 2011 | K110068 | MODEL PM3030 Omron Healthcare, Inc. | NUH |
| Oct 21, 2011 | K112415 | LIFECARE ARM & LEG PAIN RELIEF SYSTEM Everyway Medical Instruments Co.,Ltd, TW | NUH |
| Oct 18, 2011 | K110716 | EVERYWAY LOW BACK PAIN RELIEF SYSTEM Everyway Medical Instruments Co.,Ltd, TW | NUH |
| Aug 3, 2011 | K110707 | CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIMULATOR Shenzhen Dongdixin Technology Co., Ltd., CN | NUH |
| Jul 29, 2011 | K102051 | PAIN BUDDY Biomedical Life Systems, Inc. | NUH |
| May 13, 2011 | K102598 | HI-DOW-XP Hi-Dow International, Inc. | NUH |
| Jul 15, 2010 | K100441 | XINIWAVE, MODEL XW-18 International Trade Group, Inc. | NUH |
| Apr 15, 2010 | K100116 | LASERTOUCHONE (OTC) Laser Health Technologies, LLC | NUH |
| Feb 5, 2010 | K091757 | OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407 Well-Life Healthcare Limited, TW | NUH |
| May 6, 2009 | K090042 | PAINMASTER MCT PATCH Newmark, Inc. | NUH |
| Dec 3, 2007 | K060846 | THERAPEUTIC MASSAGE COMPANION Endurance Therapeutics, CA | NUH |
| May 24, 2007 | K063743 | RHYTHM TOUCH Q 2-WAY Shockim Enterprises, Ltd. | NUH |
| Feb 9, 2007 | K062532 | ELECTROPULSE - LOW BACK PAIN Pain Relief Technologies | NUH |
| Feb 7, 2007 | K063660 | OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407 Well-Life Healthcare Limited, HK | NUH |
| Apr 28, 2006 | K060222 | LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP Gemore Technology Co, Ltd., TW | NUH |
| Mar 17, 2006 | K052785 | OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406 Well-Life Healthcare Limited, HK | NUH |
| Aug 25, 2004 | K033122 | 5000Z SYSTEM (OTC) Prizm Medical, Inc. | NUH |
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