Cleared Traditional

PROPIOCEPTOR MASSAGER (K760616) - FDA 510(k) Clearance

Class I Physical Medicine device.

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.

View all Cellers Research, Inc. devices

Submission Details

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
98d slower than avg
Panel avg: 115d · This submission: 213d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.