Cleared Traditional

RESTORE, THERMACELLS (HOT PACK I) (K953442) - FDA 510(k) Clearance

Class I Physical Medicine device.

K953442 · Neal Dunning Assoc., Inc. · Physical Medicine device
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Oct 1995
Decision
106d
Days
Class 1
Risk

K953442 is an FDA 510(k) clearance for the RESTORE, THERMACELLS (HOT PACK I). Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by Neal Dunning Assoc., Inc. (Bethesda, US). The FDA issued a Cleared decision on October 31, 1995 after a review of 106 days - within the typical 510(k) review window.

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: 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 Neal Dunning Assoc., Inc. devices

Submission Details

510(k) Number K953442 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 17, 1995
Decision Date October 31, 1995
Days to Decision 106 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
9d faster than avg
Panel avg: 115d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 81
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