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510(k) K771633

HEEL PROTECTOR by Medical Restraints, Inc. — Product Code FMP

K771633 is an FDA 510(k) premarket notification submitted by Medical Restraints, Inc. for the device "HEEL PROTECTOR". The FDA issued a decision of Substantially Equivalent on September 12, 1977. The device falls under product code FMP (Protector, Skin Pressure), a Class I device regulated under 21 CFR 880.6450. Medical Restraints, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1977
Date Received
August 26, 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 Medical Restraints, Inc.

  • K771629 — HAND RESTRAINT (September 30, 1977)
  • K771630 — LIMB RESTRAINT (September 30, 1977)
  • K771636 — BODY RESTRAINT (September 30, 1977)
  • K771715 — PELVIC WHEELCHAIR RESTRAINT (September 28, 1977)
  • K771632 — FINGER MITT RESTRAINT (September 28, 1977)
  • K771635 — FOOT ELEVATOR (September 28, 1977)
  • K771634 — VEST RESTRAINT (September 28, 1977)
  • K771676 — FOOT DROP BOOT (September 20, 1977)
  • K771631 — WHEELCHAIR SAFETY BELT (September 12, 1977)

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