Cleared Traditional

K760616 - PROPIOCEPTOR MASSAGER

K760616 is an FDA 510(k) clearance for PROPIOCEPTOR MASSAGER, manufactured by Cellers Research, Inc.. The device is a Class 1 Physical Medicine device with product code ISA cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K760616 · Cellers Research, Inc. · Physical Medicine device
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Jan 1977
Decision
213d
Days
Class 1
Risk

K760616 is an FDA 510(k) clearance for the PROPIOCEPTOR MASSAGER. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Cellers Research, Inc. (Walker, US). The FDA issued a Cleared decision on January 13, 1977 after a review of 213 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5660 - 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 - K760616

510(k) Number K760616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1976
Decision Date January 13, 1977
Days to Decision 213 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
97d slower than avg
Panel avg: 116d · This submission: 213d
Pathway characteristics
Predicate-based equivalence.

ISA Device Classification - Class 1, General Controls

Product Code ISA Massager, Therapeutic, Electric
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5660
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.

K760616 · PROPIOCEPTOR MASSAGER
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