Cleared Traditional

K891987 - BIO-STYM 250 (MUSCLE STIMULATOR)

K891987 is an FDA 510(k) clearance for BIO-STYM 250 (MUSCLE STIMULATOR), manufactured by Electronic Health Technologies, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K891987 · Electronic Health Technologies, Inc. · Physical Medicine device
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Jan 1990
Decision
282d
Days
Class 2
Risk

K891987 is an FDA 510(k) clearance for the BIO-STYM 250 (MUSCLE STIMULATOR). Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Electronic Health Technologies, Inc. (New Braunfels, US). The FDA issued a Cleared decision on January 4, 1990 after a review of 282 days - an extended review 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: 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 Electronic Health Technologies, Inc. devices

FDA 510(k) Submission Details - K891987

510(k) Number K891987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1989
Decision Date January 04, 1990
Days to Decision 282 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
167d slower than avg
Panel avg: 115d · This submission: 282d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

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 170
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