Cleared Traditional

K963768 - INSTANT HOT PACKS

K963768 is an FDA 510(k) clearance for INSTANT HOT PACKS, manufactured by Kick Ice, Inc.. The device is a Class 1 Physical Medicine device with product code IMD cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K963768 · Kick Ice, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
67d
Days
Class 1
Risk

K963768 is an FDA 510(k) clearance for the INSTANT HOT PACKS. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by Kick Ice, Inc. (Johnson City, US). The FDA issued a Cleared decision on November 25, 1996 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5710 - the FDA physical medicine 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 Kick Ice, Inc. devices

FDA 510(k) Submission Details - K963768

510(k) Number K963768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1996
Decision Date November 25, 1996
Days to Decision 67 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 115d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

IMD Device Classification - Class 1, General Controls

Product Code IMD Pack, Hot Or Cold, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5710
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 - IMD Pack, Hot Or Cold, Disposable

All 32
Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K963768.
ALLEGIANCE KWIK HEAT WARM PERINEAL PACK
K973770 · Allegiance Healthcare Corp. · Nov 1997
KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD)
K970399 · Allegiance Healthcare Corp. · Apr 1997
RECOVER ADULT VEIN WARMER
K963689 · Florida Medical Industries, Inc. · Dec 1996
INSTANT COLD PACK
K963666 · Kick Ice, Inc. · Oct 1996
TEMPRA COLD PACK, REORDER NO. TC150
K963220 · Tempo Technology, Inc. · Oct 1996
IMNI HOT PACKS
K955788 · Omni Therm, Inc. · Sep 1996