Cleared Traditional

K770164 - FINGER MUSCLE TESTER

K770164 is an FDA 510(k) clearance for FINGER MUSCLE TESTER, manufactured by Bel-Art Products. The device is a Class 2 Physical Medicine device with product code ISD cleared through the Traditional 510(k) pathway after a 3-day FDA review.

K770164 · Bel-Art Products · Physical Medicine device
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Jan 1977
Decision
3d
Days
Class 2
Risk

K770164 is an FDA 510(k) clearance for the FINGER MUSCLE TESTER. Classified as Exerciser, Measuring (product code ISD), Class II - Special Controls.

Submitted by Bel-Art Products (Mchenry, US). The FDA issued a Cleared decision on January 28, 1977 after a review of 3 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5360 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bel-Art Products devices

FDA 510(k) Submission Details - K770164

510(k) Number K770164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1977
Decision Date January 28, 1977
Days to Decision 3 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
112d faster than avg
Panel avg: 115d · This submission: 3d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ISD Device Classification - Class 2, Special Controls

Product Code ISD Exerciser, Measuring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5360
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.