Cleared Traditional

K830757 - HOT/ICE

K830757 is the FDA 510(k) clearance for HOT/ICE by Thermo Temp, Inc.. It is a Class 2 Physical Medicine device (product code ILO) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K830757 · Thermo Temp, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1983
Decision
19d
Days
Class 2
Risk

K830757 is an FDA 510(k) clearance for the HOT/ICE. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Thermo Temp, Inc. (Walker, US). The FDA issued a Cleared decision on March 29, 1983 after a review of 19 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 Thermo Temp, Inc. devices

Submission Details

510(k) Number K830757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1983
Decision Date March 29, 1983
Days to Decision 19 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 115d · This submission: 19d
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.