Cleared Traditional

K940160 - TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM

K940160 is an FDA 510(k) clearance for TS1000 PORTABLE DISPOSABLE COLD THERAPY..., manufactured by Burke Neutech, Inc.. The device is a Class 2 Physical Medicine device with product code ILO cleared through the Traditional 510(k) pathway after a 135-day FDA review.

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.

FDA 510(k) Submission Details - K940160

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
19d slower than avg
Panel avg: 116d · This submission: 135d
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 88
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K940160.
ISOCOMFORTER
K936143 · Isocomforter, Inc. · Jul 1994
ORTHO TECH CRYOLOGIC SYSTEM
K940429 · Orthopedic Technology, Inc. · Jul 1994
THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS)
K940858 · Innovation Sports, Inc. · Jul 1994
HYDROT
K930918 · Sanker Intl., Inc. · May 1994
COOL-AID
K931203 · Seabrook Medical Systems, Inc. · Feb 1994
HOT/ICE SYSTEM STERILE CONFORMABLE/DISP. BLANKETS
K931843 · Hollister, Inc. · Feb 1994
K940160 · TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM
Download PDF Burke Neutech, Inc.