Cleared Traditional

K955736 - STIM-8

K955736 is an FDA 510(k) clearance for STIM-8, manufactured by Bmr , Ltd.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K955736 · Bmr , Ltd. · Physical Medicine device
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May 1996
Decision
156d
Days
Class 2
Risk

K955736 is an FDA 510(k) clearance for the STIM-8. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Bmr , Ltd. (Laurel, US). The FDA issued a Cleared decision on May 22, 1996 after a review of 156 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 Bmr , Ltd. devices

FDA 510(k) Submission Details - K955736

510(k) Number K955736 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 18, 1995
Decision Date May 22, 1996
Days to Decision 156 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 115d · This submission: 156d
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 249
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K955736.
MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR
K962462 · Smith and Nephew Donjoy, Inc. · Sep 1996
ELECTRONIC MUSCLE STIMULATOR MODEL EMS-1C/EMS-2C
K960457 · Med Labs, Inc. · Sep 1996
HANDMASTER NMS1
K952273 · Neuromusclar Electrical Stimulation Systems, Ltd. · May 1996
VST-10, VST-10/2
K960433 · Vcare Intl., Inc. · May 1996
AXIOM-HVG
K955146 · Axiom Manufacturing · May 1996
ULTRA III
K960096 · Excel Tech. , Ltd. · Mar 1996