Cleared Traditional

K963108 - HEELBO QUILTED TORSO RESTRAINT

K963108 is an FDA 510(k) clearance for HEELBO QUILTED TORSO RESTRAINT, manufactured by Hollister, Inc.. The device is a Class 1 General Hospital device with product code FMQ cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K963108 · Hollister, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
58d
Days
Class 1
Risk

K963108 is an FDA 510(k) clearance for the HEELBO QUILTED TORSO RESTRAINT. Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on October 9, 1996 after a review of 58 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 Hollister, Inc. devices

FDA 510(k) Submission Details - K963108

510(k) Number K963108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1996
Decision Date October 09, 1996
Days to Decision 58 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 129d · This submission: 58d
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 122
Devices cleared under the same product code (FMQ) and FDA review panel - the closest regulatory comparables to K963108.
HEELBO WRAP AROUND VEST
K963294 · Heelbo, Inc. · Oct 1996
THE L-BOW ARM RESTRAINT
K962778 · Heelbo, Inc. · Oct 1996
GREAT HANDS MITTS
K962810 · Heelbo, Inc. · Oct 1996
HEELBO ICU 911 BLAZER SLEEVED JACKET
K963237 · Heelbo, Inc. · Oct 1996
SLEEPER JACKET/HOUDINI SAFETY SLEEPER
K963457 · Skil-Care Corp. · Oct 1996
ROLL BELT
K963460 · Skil-Care Corp. · Oct 1996