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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: IRP FDA class 2

    Massager, Powered Inflatable Tube

    Physical Medicine

    View full classification →

    A powered inflatable tube massager is a device that uses air-filled inflatable tubes or bladders, powered by a pump, to apply cyclical pressure and massage to body areas for therapeutic purposes such as improving circulation and reducing muscle tension. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is IRP, regulated under 21 CFR 890.5650, within the Physical Medicine medical specialty. This device is eligible for third party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)
    Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)
    Air Compression Leg Massager (K-705)
    Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)
    Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La
    Air Pressure Therapy System
    SACS PRO
    Leg Massager (Models:RP-ALM070H, RP-ALM071H)
    Air Pressure Therapy System (VU-IPC04B)
    Xrecovery (XR-001)
    Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4)
    Air compression Leg Massager (MM0520, MM0521, MM0522)
    JetBoots PRO Plus
    Air compression leg massager
    Air Pressure Therapy System (Model:VU-IPC4M)
    Cold Compression
    Normatec Elite
    Cold Compression Wrap Pro
    FLOWpresso
    Air Compression Recovery System
    Cold/Hot Compression
    Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401)
    Therm-X
    LF900
    Ballancer Platinum (1222)
    Air Compression Leg Massager (model: EMK-701)
    Leg and Foot Air Wave Pressure Therapy Device
    Cryo-Thermo Compression Device (FGK002)
    Leg Massager RF-ALM070
    Air Compression Leg Massager (Model: LY-670D)
    YY-A02-B Overlapped Compression Therapy
    Cryopush Cold Compression Device
    Aquilo Sports CCT1500 System
    Air Compression Leg Massager (Models: S9036C, S9036B and S9036A)
    Powered Inflatable Tube Massager - SLIM UP DRAIN
    Normatec Go
    Air Compression Therapy Device, model: ST-502
    Air Compression Leg Massager (model: FE-7204B)
    Normatec 3
    Air Pressure Foot Massager
    Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
    Air compression leg massager HY-1117A
    Air compression therapy system FO3002
    Air Compression Massager (Model LF-FT003)
    RecoveryAir PRO
    Compressible Limb and Circulation Therapy System, Model POWER-Q2300
    Air Relax Pro Model AR-4.0
    SP-1000, SP-2000
    V12 PRO
    LX9max

    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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