FDA Product Code NUH: Stimulator, Nerve, Transcutaneous, Over-the-counter
Over-the-counter nerve stimulators bring pain relief technology to the consumer market. FDA product code NUH covers transcutaneous electrical nerve stimulators available without a prescription.
These devices deliver low-level electrical impulses through skin electrodes to modulate pain signals for the temporary relief of sore or aching muscles. OTC TENS units are cleared for self-treatment of minor musculoskeletal pain in home settings.
NUH devices are Class II medical devices, regulated under 21 CFR 882.5890 and reviewed by the FDA Neurology panel.
Leading manufacturers include Everyway Medical Instruments Co.,Ltd, Well-Life Healthcare Limited and Hivox Biotek, Inc..
229
Total
229
Cleared
180d
Avg days
2004
Since
229 devices
Cleared
Apr 24, 2014
PINOOK STIMULATOR
Pinook USA
Neurology
252d
Cleared
Apr 24, 2014
COUNTER OTC TENS DEVICE
Counter Scientific Development (Gz), Ltd.
Neurology
212d
Cleared
Jan 28, 2014
OTC PATCH
Well-Life Healthcare Limited
Neurology
53d
Cleared
Jan 24, 2014
MPP
Marc Pro
Neurology
212d
Cleared
Dec 20, 2013
ELECTRONIC PULSE MASSAGER
Gurin Products, LLC
Neurology
176d
Cleared
Nov 15, 2013
ELECTRONIC PULSE STIMULATOR
Shenzhen Jingkehui Electronic Co.., Ltd.
Neurology
142d
Cleared
Nov 12, 2013
I RUNE (I-200L)
Medirune Co, Ltd.
Neurology
461d
Cleared
Sep 26, 2013
TCM MASSAGER
Anhui Jinjianqiao Med-Tech Co,. , Ltd.
Neurology
247d
Cleared
Sep 16, 2013
OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
Shenzhen Dongdixin Technology Co., Ltd.
Neurology
178d
Cleared
Sep 13, 2013
TANYX
Medecell Us, Inc.
Neurology
270d
Cleared
Jul 25, 2013
SMARTRELIEF
Chattem, Inc.
Neurology
92d
Cleared
Jul 19, 2013
T1040 AKA AURAWAVE
Endurance Therapeutics
Neurology
200d
Cleared
Apr 16, 2013
PAINMASTER MCT PATCH
Newmark, Inc.
Neurology
90d
Cleared
Mar 28, 2013
PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER
Prospera Corporation
Neurology
202d
Cleared
Nov 20, 2012
HEALTHMATEFOREVER
Healthmate International, LLC
Neurology
158d
Cleared
Sep 07, 2012
MINI PATCH
Well-Life Healthcare Limited
Neurology
126d
Cleared
Sep 04, 2012
TENS BACK PAIN RELIEF SYSTEM
Savia Limited
Neurology
299d
Cleared
Aug 20, 2012
THE PAIN PILOT (A.K.A PAIN PILOT)
Hollywog, LLC
Neurology
181d
Cleared
Mar 19, 2012
HIVOX BIOTEK INC.
Hivox Biotek, Inc.
Neurology
214d
Cleared
Mar 01, 2012
PAIN-AID
Pdi Works, LLC
Neurology
141d
Cleared
Dec 08, 2011
MODEL PM3030
Omron Healthcare, Inc.
Neurology
332d
Cleared
Oct 21, 2011
LIFECARE ARM & LEG PAIN RELIEF SYSTEM
Everyway Medical Instruments Co.,Ltd
Neurology
60d
Cleared
Oct 18, 2011
EVERYWAY LOW BACK PAIN RELIEF SYSTEM
Everyway Medical Instruments Co.,Ltd
Neurology
217d
Cleared
Aug 03, 2011
CARE BACK PAIN RELIEF STIMULATOR
Shenzhen Dongdixin Technology Co., Ltd.
Neurology
142d