Cleared Traditional

K945803 - THERMAFLEX, MODEL SD 55 C.P.M.H.

K945803 is an FDA 510(k) clearance for THERMAFLEX, manufactured by Burke Neutech, Inc.. The device is a Class 1 Physical Medicine device with product code JFA cleared through the Traditional 510(k) pathway after a 164-day FDA review.

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

FDA 510(k) Submission Details - K945803

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.

JFA Device Classification - Class 1, General Controls

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.