Cleared Traditional

K964057 - INCARE HOT/ICE SYSTEM SHOULDER BLANKET

K964057 is an FDA 510(k) clearance for INCARE HOT/ICE SYSTEM SHOULDER BLANKET, manufactured by Hollister, Inc.. The device is a Class 2 Physical Medicine device with product code ILO cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K964057 · Hollister, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
83d
Days
Class 2
Risk

K964057 is an FDA 510(k) clearance for the INCARE HOT/ICE SYSTEM SHOULDER BLANKET. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on December 31, 1996 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5720 - 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 Hollister, Inc. devices

FDA 510(k) Submission Details - K964057

510(k) Number K964057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1996
Decision Date December 31, 1996
Days to Decision 83 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
32d faster than avg
Panel avg: 115d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILO Device Classification - Class 2, Special Controls

Product Code ILO Pack, Hot Or Cold, Water Circulating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - ILO Pack, Hot Or Cold, Water Circulating

All 25
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K964057.
INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET
K973023 · Hollister, Inc. · Nov 1997
MODEL 1100 COLD THERAPY DEVICE
K970533 · Smith & Nephew, Inc. · Apr 1997
INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES)
K964006 · Hollister, Inc. · Dec 1996
INCARE HOT/ICE LITE MACHINE
K962537 · Hollister, Inc. · Nov 1996
EBI THERMAL THERAPY SYSTEM
K963261 · Electro-Biology, Inc. · Sep 1996
EBICE
K953532 · Electro-Biology, Inc. · Oct 1995