Stimulator, Nerve, Transcutaneous, Over-The-Counter
FDA product code NUH · 200 cleared devices
Class 2
Neurology
- Regulation
- 21 CFR 882.5890
- Review panel
- NE
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 2004-08-25 – 2026-09-06
TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES
NUH
2020-05-04
NUH
2020-03-14
Health Expert Electronic Stimulator (model: AST-300L)
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NUH
2019-12-19
Everyway OTC TENS/EMS Combination
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NUH
2019-12-12
Health Expert Electronic Stimulator
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NUH
2019-12-02
Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)
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NUH
2019-11-22
Healy
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NUH
2019-11-01
Combo Electrotherapy Device
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NUH
2019-10-11
Electronic Pulse Stimulator
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NUH
2019-10-10
Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)
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NUH
2019-09-21
Medi-Direct TENS Pen
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NUH
2019-09-07
Focus TENS Therapy, Model PM710-M/-L
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NUH
2019-08-16
GIM-STIM OTC TENS/EMS System
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NUH
2019-08-01
Mini TENS Therapy Device
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NUH
2019-07-30
Transcutaneous Electrical Nerve Stimulator
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NUH
2019-06-21
JKH Stimulator Plus
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NUH
2019-06-19
MHD TENS
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NUH
2019-04-26
Portable Electro-Stimulation Therapy Device
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NUH
2019-03-15
HIVOX OTC Electrical Stimulator
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NUH
2019-03-14
JKH Stimulator Plus
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NUH
2019-02-27
PAT (Pain Alleviation Technologies)
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NUH
2019-01-10
Maxpower Relief
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NUH
2018-12-07
Neck Care Therapy, Model: SYK 509B
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NUH
2018-11-26
Low-frequency Multi-function physiotherapy instrument
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NUH
2018-11-21
PlayMakar Sport Muscle Stimulator, Model PRO-500
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NUH
2018-11-09
Heat Pain Pro
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NUH
2018-10-26
V2 OTC Pain Relief TENS
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NUH
2018-10-26
A6 OTC Pain Relief TENS
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NUH
2018-09-26
Everyway Wireless TENS & EMS Unit
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NUH
2018-09-15
ThermaCare Quick Therapy TENS
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NUH
2018-09-06
Dual output digital therapy massager
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NUH
2018-08-10
iStim S2 OTC Pain Relief TENS
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NUH
2018-07-08
BMLS16-1
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NUH
2018-06-22
Wireless Pain Relieve Device
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NUH
2018-06-07
Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator
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NUH
2018-06-06
Balego TENS Digital Edition with Accessories for Pain Relief (OTC)
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NUH
2018-04-19
EV-804 OTC Pain Relief TENS
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NUH
2018-03-07
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
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NUH
2017-12-08
Wireless Pain Relieve Device Model: LT5018C
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NUH
2017-11-29
HIVOX OTC Electrical Stimulator
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NUH
2017-11-17
Dr.MUSIC 3s
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NUH
2017-11-01
Mytens Model: BW-TSX
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NUH
2017-10-19
Avail
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NUH
2017-10-18
OTC Combo TENS/EMS System
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NUH
2017-09-22
WiTouch Pro, WiTouch, Neubac
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NUH
2017-09-19
Pain Therapy Device
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NUH
2017-08-11
EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only
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NUH
2017-08-04
Hi-Dow Wireless TENS/EMS System (Model HD-5N)
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NUH
2017-06-28
Livia
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NUH
2017-05-26
IQ Technologies
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NUH
2017-05-12
Avazzia
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NUH
2017-05-11
Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203
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NUH
2017-04-29
Digital TENS Unit
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NUH
2017-04-14
Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13
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NUH
2017-02-08
Smart Pain Reliever, Model LT5019
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NUH
2016-12-20
CP Relief Wand-OTC
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NUH
2016-12-05
WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A
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NUH
2016-11-21
Electronic Pulse Stimulator
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NUH
2016-10-13
OTC TENS Device, Model PTS-IV
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NUH
2016-10-05
Painmaster MCT Patch
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NUH
2016-09-15
HBOTC Muscle and Nerve Stimulator
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NUH
2016-07-27
HANAROCare ReJu
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NUH
2016-06-03
Heat Pain Pro
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NUH
2016-05-20
CUR Model 1
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NUH
2016-05-05
Electronic Pulse Stimulator
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NUH
2016-02-12
Pain Therapy System, Model PTS-II
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NUH
2016-01-13
LL TENS 160A, LL TENS 160B
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NUH
2016-01-05
Quell
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NUH
2013-12-20
ELECTRONIC PULSE MASSAGER
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NUH
2013-11-15
ELECTRONIC PULSE STIMULATOR
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NUH
2013-11-12
I RUNE (I-200L)
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NUH
2013-09-26
TCM MASSAGER
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NUH
2013-09-16
OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
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NUH
2013-09-13
TANYX
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NUH
2013-07-25
SMARTRELIEF
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NUH
2013-07-19
T1040 AKA AURAWAVE
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NUH
2013-04-16
PAINMASTER MCT PATCH
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NUH
2013-03-28
PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER
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NUH
2012-11-20
HEALTHMATEFOREVER
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NUH
2012-09-07
MINI PATCH
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NUH
2012-09-04
TENS BACK PAIN RELIEF SYSTEM
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NUH
2012-08-20
THE PAIN PILOT (A.K.A PAIN PILOT)
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NUH
2012-03-19
HIVOX BIOTEK INC.
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NUH
2012-03-01
PAIN-AID
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NUH
2011-12-08
MODEL PM3030
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NUH
2011-10-21
LIFECARE ARM & LEG PAIN RELIEF SYSTEM
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NUH
2011-10-18
EVERYWAY LOW BACK PAIN RELIEF SYSTEM
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NUH
2011-08-03
CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIMULATOR
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NUH
2011-07-29
PAIN BUDDY
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NUH
2011-05-13
HI-DOW-XP
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NUH
2010-07-15
XINIWAVE, MODEL XW-18
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NUH
2010-04-15
LASERTOUCHONE (OTC)
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NUH
2010-02-05
OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407
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NUH
2009-05-06
PAINMASTER MCT PATCH
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NUH
2007-12-03
THERAPEUTIC MASSAGE COMPANION
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NUH
2007-05-24
RHYTHM TOUCH Q 2-WAY
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NUH
2007-02-09
ELECTROPULSE - LOW BACK PAIN
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NUH
2007-02-07
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407
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NUH
2006-04-28
LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP
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NUH
2006-03-17
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406
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NUH
2004-08-25
5000Z SYSTEM (OTC)
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