NUH · Class II · 21 CFR 882.5890

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
193–216 of 229
Cleared Apr 24, 2014
PINOOK STIMULATOR
K132563
Pinook USA
Neurology · 252d
Cleared Apr 24, 2014
COUNTER OTC TENS DEVICE
K132993
Counter Scientific Development (Gz), Ltd.
Neurology · 212d
Cleared Jan 28, 2014
OTC PATCH
K133723
Well-Life Healthcare Limited
Neurology · 53d
Cleared Jan 24, 2014
MPP
K131910
Marc Pro
Neurology · 212d
Cleared Dec 20, 2013
ELECTRONIC PULSE MASSAGER
K131933
Gurin Products, LLC
Neurology · 176d
Cleared Nov 15, 2013
ELECTRONIC PULSE STIMULATOR
K131921
Shenzhen Jingkehui Electronic Co.., Ltd.
Neurology · 142d
Cleared Nov 12, 2013
I RUNE (I-200L)
K122410
Medirune Co, Ltd.
Neurology · 461d
Cleared Sep 26, 2013
TCM MASSAGER
K130150
Anhui Jinjianqiao Med-Tech Co,. , Ltd.
Neurology · 247d
Cleared Sep 16, 2013
OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
K130802
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 178d
Cleared Sep 13, 2013
TANYX
K123866
Medecell Us, Inc.
Neurology · 270d
Cleared Jul 25, 2013
SMARTRELIEF
K131159
Chattem, Inc.
Neurology · 92d
Cleared Jul 19, 2013
T1040 AKA AURAWAVE
K124055
Endurance Therapeutics
Neurology · 200d
Cleared Apr 16, 2013
PAINMASTER MCT PATCH
K130114
Newmark, Inc.
Neurology · 90d
Cleared Mar 28, 2013
PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER
K122744
Prospera Corporation
Neurology · 202d
Cleared Nov 20, 2012
HEALTHMATEFOREVER
K121757
Healthmate International, LLC
Neurology · 158d
Cleared Sep 07, 2012
MINI PATCH
K121353
Well-Life Healthcare Limited
Neurology · 126d
Cleared Sep 04, 2012
TENS BACK PAIN RELIEF SYSTEM
K113321
Savia Limited
Neurology · 299d
Cleared Aug 20, 2012
THE PAIN PILOT (A.K.A PAIN PILOT)
K120500
Hollywog, LLC
Neurology · 181d
Cleared Mar 19, 2012
HIVOX BIOTEK INC.
K112392
Hivox Biotek, Inc.
Neurology · 214d
Cleared Mar 01, 2012
PAIN-AID
K113037
Pdi Works, LLC
Neurology · 141d
Cleared Dec 08, 2011
MODEL PM3030
K110068
Omron Healthcare, Inc.
Neurology · 332d
Cleared Oct 21, 2011
LIFECARE ARM & LEG PAIN RELIEF SYSTEM
K112415
Everyway Medical Instruments Co.,Ltd
Neurology · 60d
Cleared Oct 18, 2011
EVERYWAY LOW BACK PAIN RELIEF SYSTEM
K110716
Everyway Medical Instruments Co.,Ltd
Neurology · 217d
Cleared Aug 03, 2011
CARE BACK PAIN RELIEF STIMULATOR
K110707
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 142d