Cleared Traditional

K963243 - HEELBO BLAZER SLEEVED JACKET

K963243 is an FDA 510(k) clearance for HEELBO BLAZER SLEEVED JACKET, 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 43-day FDA review.

K963243 · Heelbo, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
43d
Days
Class 1
Risk

K963243 is an FDA 510(k) clearance for the HEELBO BLAZER SLEEVED JACKET. 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 1, 1996 after a review of 43 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 - K963243

510(k) Number K963243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1996
Decision Date October 01, 1996
Days to Decision 43 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
86d faster than avg
Panel avg: 129d · This submission: 43d
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 K963243.
SAFETY VEST/SHOULDER STRAP VEST/ECONOMY SAFETY VEST
K963450 · Skil-Care Corp. · Oct 1996
CUSHION BELT/CUSHION SLIDER BELT/ADJUSTA-LOOP CUSHION BELT/QUICK RELEASE CUSHION BELT
K963454 · Skil-Care Corp. · Oct 1996
PATIENT PROTECTIVE LIMB
K962626 · Kenad SG Medical, Inc. · Oct 1996
SAFETY VEST
K962429 · Johnson & Johnson Professionals, Inc. · Sep 1996
BED PRODUCTS
K850470 · Abco Dealers, Inc. · Apr 1985
HEAD PROTECTOR
K812473 · Maddak, Inc. · Dec 1981