Heel or Elbow Protector

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K812344 ↗

FDA Product Code

FMP

Device Class

Class I

Regulation

21 CFR Part 880.6450

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Thermoelastomer Hot/Cold Compress-7187-

  Class I

  FDA 510(k) K823650 Active Cleared 21 Jan 1983

• Bk-6157-02 C.V.A Sling, Medium&Large

  Class I

  FDA 510(k) K801713 Active Cleared 7 Aug 1980

• Non-Slip Vinyl Bath Mat

  Not classified

  FDA 510(k) K823631 Active Cleared 3 Feb 1983

• Bk-2084 Plastic Sock and Stocking Aid

  Class I

  FDA 510(k) K790171 Active Cleared 8 Feb 1979

• Bk-5058-01 Quad-Quip Wheelchair Cuff

  Class I

  FDA 510(k) K801709 Active Cleared 7 Aug 1980

• Transfer Aids

  Class I

  FDA 510(k) K810449 Active Cleared 4 Mar 1981

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