Cleared Traditional

K032652 - RS-4I MUSCLE STIMULATOR FAMILY

K032652 is an FDA 510(k) clearance for RS-4I MUSCLE STIMULATOR FAMILY, manufactured by Rs Medical. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K032652 · Rs Medical · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
15d
Days
Class 2
Risk

K032652 is an FDA 510(k) clearance for the RS-4I MUSCLE STIMULATOR FAMILY. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Rs Medical (Vancouver, US). The FDA issued a Cleared decision on September 12, 2003 after a review of 15 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.

FDA 510(k) Submission Details - K032652

510(k) Number K032652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2003
Decision Date September 12, 2003
Days to Decision 15 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 116d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 505
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K032652.
AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
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ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1
K031427 · Biomedical Life Systems, Inc. · Aug 2003
ELECTROMEDICARIN 900
K020478 · Electromedicarin, S.A. · Jul 2003
CEFAR REHAB 2 AND REHAB 2 PRO
K030403 · Cefar Medical AB · Jul 2003
K032652 · RS-4I MUSCLE STIMULATOR FAMILY
Download PDF FDA Summary Rs Medical