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510(k) K771913

HEEL/ELBOW PROTECTOR by Alba-Waldensian, Inc. — Product Code FMP

K771913 is an FDA 510(k) premarket notification submitted by Alba-Waldensian, Inc. for the device "HEEL/ELBOW PROTECTOR". The FDA issued a decision of Substantially Equivalent on November 15, 1977. The device falls under product code FMP (Protector, Skin Pressure), a Class I device regulated under 21 CFR 880.6450. Alba-Waldensian, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1977
Date Received
October 11, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protector, Skin Pressure
Device Class
Class I
Regulation Number
880.6450
Review Panel
HO
Submission Type

Other clearances by Alba-Waldensian, Inc.

  • K020592 — ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001 (April 3, 2002)
  • K961405 — ALBA HEALTH PAS WRAP SYSTEM (December 26, 1996)
  • K852091 — ALBA DRY BURN PAD (June 13, 1985)
  • K792357 — STERILE IMPERVIOUS ORTHOPEDIC STOCKIN (December 18, 1979)
  • K781964 — COMPRESSION DEVICES, LIMB (December 12, 1978)
  • K780570 — TUBULAR DRESSING RETAINER (April 19, 1978)
  • K780547 — STERILE ORTHOPEDIC STOCKINETTE (April 10, 1978)

Other clearances for product code FMP

  • K150243 — Invictus Medical GelShield (May 1, 2015)
  • K951325 — COMFEEL PLUS PRESSURE RELIEF DRESSING (July 31, 1995)
  • K934731 — MEDSURG STERILE IMAGING PRODUCTS (March 28, 1994)
  • K820584 — DECUBICARE PADS & ACCESSORIES (March 25, 1982)
  • K812344 — HEEL OR ELBOW PROTECTOR (September 11, 1981)
  • K811184 — SPENCO DERMAL PADS (May 20, 1981)
  • K802829 — SCANLAN VASCU-STATT (January 15, 1981)
  • K802185 — ARTERIAL BLOOD SAMPLING KIT (October 10, 1980)
  • K801694 — FLOTATION PAD FOR OPERATING TABLE (August 27, 1980)
  • K801195 — DERMALEX OR NATRAWOOL SKIN PRESSURE PROT (June 9, 1980)

FDA data resources