Cleared Traditional

K870774 - TRU-STIM MUSCLE STIMULATOR

K870774 is the FDA 510(k) clearance for TRU-STIM MUSCLE STIMULATOR by Briefcase, Inc.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K870774 · Briefcase, Inc. · Physical Medicine device
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Mar 1987
Decision
20d
Days
Class 2
Risk

K870774 is an FDA 510(k) clearance for the TRU-STIM MUSCLE STIMULATOR. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Briefcase, Inc. (Mill Valley, US). The FDA issued a Cleared decision on March 18, 1987 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - 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 Briefcase, Inc. devices

Submission Details

510(k) Number K870774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1987
Decision Date March 18, 1987
Days to Decision 20 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
95d faster than avg
Panel avg: 115d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 150
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K870774.
MYOSTIM(TM), MODEL 6600
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INTERSTIM 100 SYSTEM
K861136 · Buckman Co., Inc. · Jul 1986