Cleared Traditional

K960457 - ELECTRONIC MUSCLE STIMULATOR MODEL EMS-1C/EMS-2C

K960457 is an FDA 510(k) clearance for ELECTRONIC MUSCLE STIMULATOR MODEL EMS-..., manufactured by Med Labs, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K960457 · Med Labs, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
220d
Days
Class 2
Risk

K960457 is an FDA 510(k) clearance for the ELECTRONIC MUSCLE STIMULATOR MODEL EMS-1C/EMS-2C. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Med Labs, Inc. (Goleta, US). The FDA issued a Cleared decision on September 6, 1996 after a review of 220 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 Med Labs, Inc. devices

FDA 510(k) Submission Details - K960457

510(k) Number K960457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1996
Decision Date September 06, 1996
Days to Decision 220 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 115d · This submission: 220d
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 K960457.
AXIOM INF
K964423 · Axiom Manufacturing · Jan 1997
XH-1 NEUROMUSCULAR STIMULATOR
K950550 · California Medical Research Institute · Dec 1996
MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR
K962462 · Smith and Nephew Donjoy, Inc. · Sep 1996
HANDMASTER NMS1
K952273 · Neuromusclar Electrical Stimulation Systems, Ltd. · May 1996
STIM-8
K955736 · Bmr , Ltd. · May 1996
VST-10, VST-10/2
K960433 · Vcare Intl., Inc. · May 1996