Cleared Traditional

TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM (K940160) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K940160 · Burke Neutech, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
135d
Days
Class 2
Risk

K940160 is an FDA 510(k) clearance for the TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Burke Neutech, Inc. (Largo, US). The FDA issued a Cleared decision on May 27, 1994 after a review of 135 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Burke Neutech, Inc. devices

Submission Details

510(k) Number K940160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1994
Decision Date May 27, 1994
Days to Decision 135 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 115d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 92
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K940160.
Armory Motion
K213097 · Pain Management Technologies, Inc. · Jun 2022
MODEL 1100 COLD THERAPY DEVICE
K970533 · Smith & Nephew, Inc. · Apr 1997
THERMOCOOL SYSTEM
K950395 · Zimmer, Inc. · Aug 1995
HYPER-K HEAT SYSTEM
K912722 · Baxter Healthcare Corp · Sep 1991
K-MODULE II HEAT THERAPY SYSTEM
K910061 · Baxter Healthcare Corp · Feb 1991