Cleared Traditional

K963099 - HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET

K963099 is an FDA 510(k) clearance for HEELBO PULLOVER PONCHO AND PULLOVER PON..., 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 84-day FDA review.

K963099 · Heelbo, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
84d
Days
Class 1
Risk

K963099 is an FDA 510(k) clearance for the HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET. Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by Heelbo, Inc. (Libertyville, US). The FDA issued a Cleared decision on November 1, 1996 after a review of 84 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 - K963099

510(k) Number K963099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1996
Decision Date November 01, 1996
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
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 K963099.
ECONOMY SAFETY VEST RESTRAINT, SHOULDER TIE SAFETY VEST/SAFETY VEST RESTRAINT, HEAVY DUTY VEST RESTRAINT, MESH SAFETY VE
K963435 · Zimmer Patient Care Division · Nov 1996
MORRISON MEDICAL DISPOSABLE RESTRAINT STRAP
K963494 · Morrison Medical Products · Nov 1996
HEELBO SECURITY BELT
K963060 · Heelbo, Inc. · Nov 1996
HEELBO PELVIC RESTRAINT
K963199 · Hollister, Inc. · Nov 1996
HEELBO LIFE JACKET WITH CROTCH SUPPORT
K963041 · Heelbo, Inc. · Oct 1996
MESH VEST RESTRAINT WITH SLEEVES WRIST/ANKLE RESTRAINT
K963393 · Depuy, Inc. · Oct 1996