Cleared Traditional

K962831 - THE INCH QUILTED LIMB HOLDER WITH QUICK RELEASE SNAP CLOSURE

K962831 is an FDA 510(k) clearance for THE INCH QUILTED LIMB HOLDER WITH QUICK..., manufactured by Heelbo, 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.

K962831 · Heelbo, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
88d
Days
Class 1
Risk

K962831 is an FDA 510(k) clearance for the THE INCH QUILTED LIMB HOLDER WITH QUICK RELEASE SNAP CLOSURE. Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by Heelbo, Inc. (Libertyville, US). The FDA issued a Cleared decision on October 18, 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 Heelbo, Inc. devices

FDA 510(k) Submission Details - K962831

510(k) Number K962831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1996
Decision Date October 18, 1996
Days to Decision 88 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
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 K962831.
STRAP WEDGE
K963526 · Alimed, Inc. · Oct 1996
CHECKMATE ANKLE RESTRAINT SYSTEM
K962963 · Hollister, Inc. · Oct 1996
HEELBO JOHNNY GRAIT BELT SECURITY BELT
K962964 · Hollister, Inc. · Oct 1996
HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING AND STRAP
K962832 · Heelbo, Inc. · Oct 1996
HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAP
K962834 · Heelbo, Inc. · Oct 1996
HEELBO QUILTED LIMB HOLDER WITH BUCKLE AND STRAP
K962839 · Heelbo, Inc. · Oct 1996