Cleared Traditional

THERMAFLEX, MODEL SD 55 C.P.M.H. (K945803) - FDA 510(k) Clearance

Class I Physical Medicine device.

K945803 · Burke Neutech, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
164d
Days
Class 1
Risk

K945803 is an FDA 510(k) clearance for the THERMAFLEX, MODEL SD 55 C.P.M.H.. Classified as Exerciser, Finger, Powered (product code JFA), Class I - General Controls.

Submitted by Burke Neutech, Inc. (Largo, US). The FDA issued a Cleared decision on May 11, 1995 after a review of 164 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5410 - 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 K945803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1994
Decision Date May 11, 1995
Days to Decision 164 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 115d · This submission: 164d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JFA Exerciser, Finger, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5410
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.