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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: ISA FDA class 1

    Massager, Therapeutic, Electric

    Physical Medicine

    View full classification →

    An electric therapeutic massager is an electrically powered device that delivers mechanical massage to soft tissues for therapeutic purposes including pain relief, relaxation, and improvement of local blood flow. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is ISA, regulated under 21 CFR 890.5660, within the Physical Medicine medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    VMAT PRO
    ShockPhysio Mobile (model SW3200 Basic)
    BTL-094
    Omnispec ED1000
    OW100S (model OW100S-US)
    DolorClast Radial
    OrthoGold 100
    OrthoGold 100
    D-Actor 200 Vibration Massage System
    CELLU M6 KEYMODULE I
    CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM
    JET THERAPY
    LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR
    SPIN ROLLERE
    BODYFLEX MASSAGER
    RELAXU-1
    AVON MASSAGING HAIRBRUSH
    THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES
    DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FBM-2000
    SHAPE UP MOMI ROLLER
    DR-3, DR-6, DR-68, DR-88, AMR-6, FR-22R, DR-22B
    RELAXY-THE WONDER HAND
    MASSAGER
    RELAXY-WONDER KNOCK
    AGILANCE-GOLDEN SPOONS
    FAMILY FITNESS SHIATSU MASSAGER
    STIMU-TAP
    FAMILY FITNESS SHIATSU MASSAGER
    BODY FLEX
    PRO-SHIATSU PORTABLE MASSAGER
    SHIATSU MASSAGER
    BODY SYSTEM
    WAHL(R) ULTRA COMFORT MASSAGER SPEC #89ISA
    WAHL DOUBLE COMFORT MASSAGER
    BODY RECHARGER
    MODEL 777 THERAPEUTIC MASSAGER
    AQUASSAGER WM110/W210 & WM120 BODY BASICS MASSAGER
    FO18/FO98 SCRUBOFLEX SHOWERPROOF BRUSH MASSAGER
    OMRON MASSAGER MODEL HM-45
    OMBRON TWIN-HEAD MASSAGER MODEL HM-101
    OMRON MASSAGER MODEL HM-102
    BODY RELAXER
    INFRADERM; TOUCH 'N TONE PLUS
    WINDMERE WAND MASSAGER
    WINDMERE PRELUDE III
    BODY SOOTHER
    BODY TRAINER
    HANDY VIBRO BELT
    BODY-MATE MASSAGER
    SONACARE SOUND MASSAGER

    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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