Cleared Traditional

K963547 - THE WRAP IMMOBILIZATION SYSTEM

K963547 is an FDA 510(k) clearance for THE WRAP IMMOBILIZATION SYSTEM, manufactured by Safe Restraints, Inc.. The device is a Class 1 General Hospital device with product code FMQ cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K963547 · Safe Restraints, Inc. · General Hospital
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Dec 1996
Decision
88d
Days
Class 1
Risk

K963547 is an FDA 510(k) clearance for the THE WRAP IMMOBILIZATION SYSTEM. Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by Safe Restraints, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on December 2, 1996 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6760 - 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 Safe Restraints, Inc. devices

FDA 510(k) Submission Details - K963547

510(k) Number K963547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1996
Decision Date December 02, 1996
Days to Decision 88 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 129d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

FMQ Device Classification - Class 1, General Controls

Product Code FMQ Restraint, Protective
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6760
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 - FMQ Restraint, Protective

All 121
Devices cleared under the same product code (FMQ) and FDA review panel - the closest regulatory comparables to K963547.
DISPOSABLE LIMB HOLDER
K963476 · Deroyal Industries, Inc. · Jan 1997
ROLL BELTS
K963467 · Deroyal Industries, Inc. · Jan 1997
PELVIC HOLDER
K963465 · Deroyal Industries, Inc. · Dec 1996
PATIENT RESTRAINTS
K963906 · Safety Intl., Inc. · Dec 1996
POSEY STRAIGHT JACKETS
K963410 · J. T. Posey Co. · Nov 1996
MULTIPLE BELTS
K963414 · J. T. Posey Co. · Nov 1996