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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: NUH FDA class 2

    Stimulator, Nerve, Transcutaneous, Over-The-Counter

    Neurology

    View full classification →

    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.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026)
    TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026)
    TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)
    Patch-TEA (Model TRI-21)
    Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)
    Progenix Select Stim
    POCKET TENS (EP-300)
    Nooro Body & Foot Stimulator (SM9141, SM9142)
    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)
    Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)
    Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator
    TENS & EMS Stimulator (MHD-1083)
    Pixie Pulse (SM9068)
    Transcutaneous Electrical Nerve Stimulator (K6106)
    Wireless TENS & EMS (Model SM9110,SM9113,SM9116)
    TENS&EMS units (SM9109A, SM9109B)
    Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)
    Transcutaneous Electrical Nerve Stimulator (9029SCM)
    Electrical Stimulator System
    S21 OTC Transcutaneous Electrical Nerve Stimulator
    Muscle Stimulator
    ENSO (Model 2)
    EMS/TENS Massager Device
    Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)
    Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)
    Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)
    Ova+ (K-OVAP-USA)
    Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)
    ManaFlexx 2 (model: MF002-RX, MF002-OTC)
    Heating Tens, FT-615
    Unicare (K-UNICARE-USA)
    Nu-beca Transcutaneous Electrical Nerve Stimulation
    TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)
    HEATING TENS/EMS, FT-810R
    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
    Tens & Ems Device
    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)
    TENS7000 Rechargeable (Model:TENS7000 Rechargeable)
    TENS and EMS Stimulation (OTC)
    TENS and EMS Stimulation (OTC)
    TENS and EMS Stimulation (OTC)
    AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)
    Everyway Analog OTC TENS
    Electronic Pulse Stimulator
    Transcutaneous Electrical Nerve Stimulator Model: ST-304
    Wireless TENS/EMS, Bruno, Aela
    Transcutaneous Electrical Nerve Stimulator, Model: KTR-405
    Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)
    Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)
    Noodle

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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