Cleared Traditional

K771633 - HEEL PROTECTOR

K771633 is the FDA 510(k) clearance for HEEL PROTECTOR by Medical Restraints, Inc.. It is a Class 1 General Hospital device (product code FMP) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K771633 · Medical Restraints, Inc. · General Hospital
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Sep 1977
Decision
17d
Days
Class 1
Risk

K771633 is an FDA 510(k) clearance for the HEEL PROTECTOR. Classified as Protector, Skin Pressure (product code FMP), Class I - General Controls.

Submitted by Medical Restraints, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1977 after a review of 17 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6450 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medical Restraints, Inc. devices

Submission Details

510(k) Number K771633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1977
Decision Date September 12, 1977
Days to Decision 17 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 129d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FMP Protector, Skin Pressure
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6450
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FMP Protector, Skin Pressure

All 7
Devices cleared under the same product code (FMP) and FDA review panel - the closest regulatory comparables to K771633.
HEEL OR ELBOW PROTECTOR
K812344 · Fred Sammons, Inc. · Sep 1981
SPAN AIDS KIT
K792297 · American Hospital Supply Corp. · Dec 1979
HEEL OR ELBOW PROTECTOR
K772419 · Fred Sammons, Inc. · Jan 1978
SPECIALIST ARM & LEG PROTECTOR
K771519 · Johnson & Johnson Professionals, Inc. · Aug 1977
PROTECTOR, HEEL & ELBOW
K770635 · Tecnol New Jersey Wound Care, Inc. · May 1977