BEUDAMED
    Product Code: NUH FDA class 2 21 CFR 882.5890

    Stimulator, Nerve, Transcutaneous, Over-The-Counter

    Neurology

    The Over-the-Counter Transcutaneous Nerve Stimulator is a TENS device intended for temporary relief of pain due to sore and aching muscles, available for consumer purchase without a prescription. It delivers electrical impulses through the skin to modulate pain signals. It is an FDA Class 2 device regulated under 21 CFR 882.5890 in the Neurology specialty, with product code NUH, requiring 510(k) clearance. Third-party review is available. It is not an implant and does not carry life-sustaining support designation.

    View on FDA
    510(k)s
    228
    FEI Numbers
    160
    Registration Numbers
    160
    Unique Applicants
    119
    Years Active
    22

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    Basic Information

    Product Code
    NUH
    Device Class
    FDA class 2
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 228 510(k) clearances via K numbers.

    K Number Device Name
    K260425 TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)
    K253896 TENS/EMS device (GUSE01)
    K253305 TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
    K253740 TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
    K251958 VEINOPLUS Back
    K252688 Transcutaneous Electrical Nerve Stimulator (RJTENS-2)
    K251856 Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4
    K243131 Triathlon Pro
    K251429 OTC 4-Channel Rechargeable TENS Unit
    K250784 Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122)
    K251187 3 in 1 TENS UNIT (TC1241, TC2241, TS1241)
    K243856 TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026)
    K250360 TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026)
    K250053 TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)
    K243613 Patch-TEA (Model TRI-21)
    K250033 Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)
    K242460 Progenix Select Stim
    K242815 POCKET TENS (EP-300)
    K243334 Nooro Body & Foot Stimulator (SM9141, SM9142)
    K242332 Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494)
    K242567 Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)
    K233054 Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator
    K241678 TENS & EMS Stimulator (MHD-1083)
    K241365 Pixie Pulse (SM9068)
    K241119 Transcutaneous Electrical Nerve Stimulator (K6106)
    K233067 Wireless TENS & EMS (Model SM9110,SM9113,SM9116)
    K241509 TENS&EMS units (SM9109A, SM9109B)
    K231425 Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)
    K240292 Transcutaneous Electrical Nerve Stimulator (9029SCM)
    K232439 Electrical Stimulator System
    K233095 S21 OTC Transcutaneous Electrical Nerve Stimulator
    K231648 Muscle Stimulator
    K233784 ENSO (Model 2)
    K233092 Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)
    K233040 EMS/TENS Massager Device
    K231423 Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)
    K233461 Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)
    K230926 Ova+ (K-OVAP-USA)
    K232517 Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)
    K231569 ManaFlexx 2 (model: MF002-RX, MF002-OTC)
    K232675 Heating Tens, FT-615
    K231053 Unicare (K-UNICARE-USA)
    K223151 Nu-beca Transcutaneous Electrical Nerve Stimulation
    K230443 TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)
    K223308 HEATING TENS/EMS, FT-810R
    K222870 Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039
    K223825 Tens & Ems Device
    K223428 Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A)
    K230829 TENS7000 Rechargeable (Model:TENS7000 Rechargeable)
    K230164 TENS and EMS Stimulation (OTC)
    K230174 TENS and EMS Stimulation (OTC)
    K230163 TENS and EMS Stimulation (OTC)
    K222867 AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)
    K222488 Everyway Analog OTC TENS
    K221992 Electronic Pulse Stimulator
    K221092 Transcutaneous Electrical Nerve Stimulator Model: ST-304
    K220997 Wireless TENS/EMS, Bruno, Aela
    K220998 Transcutaneous Electrical Nerve Stimulator, Model: KTR-405
    K220524 Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)
    K221251 Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)
    K220573 Noodle
    K221384 Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2
    K213788 TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)
    K220283 TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)
    K220152 TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)
    K212377 Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01
    K220005 TENS & PMS Unit
    K212184 TENS and EMS Stimulation (OTC)
    K213741 TENS & EMS DEVICE (Model: FM-B2403A)
    K213835 TENS & EMS Device
    K213091 Well-Life TENS/EMS/Heating Stimulator
    K220150 TENS & PMS (Model: SM9126)
    K211263 Intrelief
    K212285 Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)
    K210223 Transcutaneous Electrical Nerve Stimulator
    K212918 Heat StimPlus
    K212989 Low-frequency Stimulator (Model: AST-645, AST-646)
    K202671 DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)
    K211403 HIVOX OTC Electrical Stimulator, FT610-B
    K200558 Smart Neck Stimulator
    K211736 Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)
    K210756 Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H
    K200694 Perfect EMS
    K202866 TENS & EMS Device
    K200177 Low-frequency Multi-function physiotherapy instrument
    K203574 HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2
    K202849 Everyway Analog OTC TENS, model N103A/N302
    K202470 Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300
    K202317 Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806
    K201335 Li-Battery powered OTC TENS/EMS Combination Stimulator
    K200237 Transcutaneous Electronic Nerve Stimulator
    K191982 Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)
    K193655 MSLS6QF TENS/PMS Device
    K200838 Tyece OTC TENS Model
    K200561 StimPlus Patch, StimPlus Patch, StimPlus Patch
    K200354 Electronic stimulator
    K200727 TENS and Muscle Stimulator
    K192201 Electrical Stimulator System
    K183110 LIVIA
    K190783 Health Expert Electronic Stimulator (model: AST-300L)
    K192589 Everyway OTC TENS/EMS Combination
    K190673 Health Expert Electronic Stimulator
    K190009 Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)
    K191075 Healy
    K192087 Combo Electrotherapy Device
    K183674 Electronic Pulse Stimulator
    K182136 Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)
    K182671 Medi-Direct TENS Pen
    K183215 Focus TENS Therapy, Model PM710-M/-L
    K190988 GIM-STIM OTC TENS/EMS System
    K182871 Mini TENS Therapy Device
    K183288 Transcutaneous Electrical Nerve Stimulator
    K191151 JKH Stimulator Plus
    K190115 MHD TENS
    K182108 Portable Electro-Stimulation Therapy Device
    K190347 HIVOX OTC Electrical Stimulator
    K182203 JKH Stimulator Plus
    K182267 PAT (Pain Alleviation Technologies)
    K182120 Maxpower Relief
    K172897 Neck Care Therapy, Model: SYK 509B
    K172837 Low-frequency Multi-function physiotherapy instrument
    K182581 PlayMakar Sport Muscle Stimulator, Model PRO-500
    K181992 Heat Pain Pro
    K182767 V2 OTC Pain Relief TENS
    K182753 A6 OTC Pain Relief TENS
    K181707 Everyway Wireless TENS & EMS Unit
    K181102 ThermaCare Quick Therapy TENS
    K172834 Dual output digital therapy massager
    K181849 iStim S2 OTC Pain Relief TENS
    K172971 BMLS16-1
    K180331 Wireless Pain Relieve Device
    K180956 Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator
    K181207 Balego TENS Digital Edition with Accessories for Pain Relief (OTC)
    K172919 EV-804 OTC Pain Relief TENS
    K171802 ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
    K173462 Wireless Pain Relieve Device Model: LT5018C
    K171803 HIVOX OTC Electrical Stimulator
    K172451 Dr.MUSIC 3s
    K171026 Mytens Model: BW-TSX
    K172079 Avail
    K172809 OTC Combo TENS/EMS System
    K171599 WiTouch Pro, WiTouch, Neubac
    K163611 Pain Therapy Device
    K163166 EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only
    K163393 Hi-Dow Wireless TENS/EMS System (Model HD-5N)
    K163153 Livia
    K170659 IQ Technologies
    K162392 Avazzia
    K170205 Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203
    K170145 Digital TENS Unit
    K162517 Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13
    K162479 Smart Pain Reliever, Model LT5019
    K162630 CP Relief Wand-OTC
    K161453 WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A
    K160508 Electronic Pulse Stimulator
    K161537 OTC TENS Device, Model PTS-IV
    K151995 Painmaster MCT Patch
    K160255 HBOTC Muscle and Nerve Stimulator
    K160893 HANAROCare ReJu
    K160115 Heat Pain Pro
    K160052 CUR Model 1
    K153520 Electronic Pulse Stimulator
    K150277 Pain Therapy System, Model PTS-II
    K152374 LL TENS 160A, LL TENS 160B
    K152954 Quell
    K152128 2-in-1 Abdominal Muscle Training & Back Pain Relief System
    K152852 ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)
    K151279 Counter OTC TENS Device, Model CSD-737Z
    K151034 PainKARE
    K150386 Tyece OTC TENS Device
    K150308 Palm TENS
    K151479 EV-820 OTC Pain Relief TENS
    K150043 Transcutaneous Electrical Nerve Stimulators (TENS)
    K151035 PulseRelief
    K143268 TENS AND POWERED MUSCLE STIMULATOR
    K150995 Electronic Pulse Stimulator
    K143430 SmartTENS
    K150681 GEMORE OTC TENS
    K133789 DOLPHIN NEUROSTIM OTC
    K142686 StimPad OTC
    K141978 MAXPOWER RELIEF
    K133502 5000Z FIREFLY SYSTEM
    K141299 OTC COMBO TENS/EMS SYSTEM
    K133929 HEALTH EXPERT ELCTRONIC STIMULATOR
    K141260 ELECTRONIC PULSE STIMULATOR
    K140168 EASYSTIM TN28_OTC
    K133979 TENS
    K131290 IQ TECHNOLOGIES
    K140333 ASCEND
    K140650 HIVOX ELECTRIC STIMULATOR OTC TENS
    K132993 COUNTER OTC TENS DEVICE
    K132563 PINOOK STIMULATOR
    K131956 QUICK RELAX PRO
    K133723 OTC PATCH
    K131910 MPP
    K131933 ELECTRONIC PULSE MASSAGER
    K131921 ELECTRONIC PULSE STIMULATOR
    K122410 I RUNE (I-200L)
    K130150 TCM MASSAGER
    K130802 OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
    K123866 TANYX
    K131159 SMARTRELIEF
    K124055 T1040 AKA AURAWAVE
    K130114 PAINMASTER MCT PATCH
    K122744 PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER
    K121757 HEALTHMATEFOREVER
    K121353 MINI PATCH
    K113321 TENS BACK PAIN RELIEF SYSTEM
    K120500 THE PAIN PILOT (A.K.A PAIN PILOT)
    K112392 HIVOX BIOTEK INC.
    K113037 PAIN-AID
    K110068 MODEL PM3030
    K112415 LIFECARE ARM & LEG PAIN RELIEF SYSTEM
    K110716 EVERYWAY LOW BACK PAIN RELIEF SYSTEM
    K110707 CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIMULATOR
    K102051 PAIN BUDDY
    K102598 HI-DOW-XP
    K100441 XINIWAVE, MODEL XW-18
    K100116 LASERTOUCHONE (OTC)
    K091757 OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407
    K090042 PAINMASTER MCT PATCH
    K060846 THERAPEUTIC MASSAGE COMPANION
    K063743 RHYTHM TOUCH Q 2-WAY
    K062532 ELECTROPULSE - LOW BACK PAIN
    K063660 OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407
    K060222 LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP
    K052785 OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406
    K033122 5000Z SYSTEM (OTC)

    FEI Numbers

    This FDA classification entry is associated with 160 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 160 registration numbers. Click on an entry to view related FDA registrations.