BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ACE COLD BANDAGE

    K Number: K810402 · Decision Mar 4, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    467
    Registration Numbers
    468
    Same Product Code
    26
    Applicant Total
    632
    Review Days
    14

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ACE COLD BANDAGE
    K Number
    K810402
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5700
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    February 18, 1981
    Decision Date
    March 4, 1981
    Product Code
    IME
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IME Pack, Hot Or Cold, Reusable

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (IME), ordered by most recent decision date.

    COLD PACK

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    HOTPAD

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    HOT OR COLD PACK (THERMIPAQ)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SUBOCCIPITAL ICE PILLOW

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    RE-HEATER, HOT PACK

    FDA 510(k)
    FDA Class 1 ·Physical Medicine
    View all

    Other Clearances by Bd Becton Dickinson Vacutainer Systems Preanalytic

    K Number Device Name
    K003062 BACTEC MGIT 960 SIR KITS
    K003553 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
    K003461 BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
    K002938 B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16
    K001364 BD DIRECTIGEN FLU A+B
    K000762 MOXIFLOXACIN, 5 UG, BBL SENSI-DISC
    K000829 GATIFLOXACIN, 5 UG, BBL SENSI-DISC
    K993186 SYNERCID, 15 UG, BBL SENSI-DISC
    K992734 BECTON DICKINSON SYRINGE
    K991551 VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE
    Search all 632 clearances from Bd Becton Dickinson Vacutainer Systems Preanalytic →