Cleared Traditional

K971542 - ORTHO DX NEUROMUSCULAR STIMULATOR

K971542 is an FDA 510(k) clearance for ORTHO DX NEUROMUSCULAR STIMULATOR, manufactured by Rehabilicare, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K971542 · Rehabilicare, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
108d
Days
Class 2
Risk

K971542 is an FDA 510(k) clearance for the ORTHO DX NEUROMUSCULAR STIMULATOR. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Rehabilicare, Inc. (New Brighton, US). The FDA issued a Cleared decision on August 14, 1997 after a review of 108 days - within the typical 510(k) review window.

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 Rehabilicare, Inc. devices

FDA 510(k) Submission Details - K971542

510(k) Number K971542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1997
Decision Date August 14, 1997
Days to Decision 108 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
7d faster than avg
Panel avg: 115d · This submission: 108d
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 196
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K971542.
SD-970EMS ELECTRICAL MUSCULAR STIMULATOR
K964434 · Skylark Device Co., Ltd. · Oct 1997
IMPULSE HVG
K970847 · Armstrong Industries, Inc. · Sep 1997
MSI MAGNA-STYM
K972055 · Microvas Systems, Inc. · Aug 1997
NEURO-TRAIN II (2)
K970155 · Sterne Equipment Co., Ltd. · Mar 1997
SYS STIM 226
K964028 · Mettler Electronics Corp. · Feb 1997
AXIOM INF
K964423 · Axiom Manufacturing · Jan 1997