BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Reprocessed Tri Pulse Compression Garment

    K Number: K203847 · Decision May 7, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    9
    Review Days
    127

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    Basic Information

    Device Name
    Reprocessed Tri Pulse Compression Garment
    K Number
    K203847
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Renu Medical, Inc.
    Date Received
    December 31, 2020
    Decision Date
    May 7, 2021
    Product Code
    JOW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JOW Sleeve, Limb, Compressible

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    Other Clearances by Renu Medical, Inc.

    K Number Device Name
    K121145 RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME
    K111773 RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE
    K093658 RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS FOOT GARMENTS
    K081927 RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO
    K072194 RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25
    K063661 RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20
    K051227 RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1
    K031559 RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES