Cleared Traditional

K090632 - COMPEX REHAB

K090632 is an FDA 510(k) clearance for COMPEX REHAB, manufactured by Chattanooga Group. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K090632 · Chattanooga Group · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
84d
Days
Class 2
Risk

K090632 is an FDA 510(k) clearance for the COMPEX REHAB. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Chattanooga Group (Vista, US). The FDA issued a Cleared decision on June 1, 2009 after a review of 84 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 - K090632

510(k) Number K090632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2009
Decision Date June 01, 2009
Days to Decision 84 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
32d faster than avg
Panel avg: 116d · This submission: 84d
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 422
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K090632.
MAXEMS, MODELS 1000 AND 2000
K091248 · Bio Protech, Inc. · Nov 2009
T.E.A.R. TECH3
K090532 · Vision Quest Industries, Inc. · Nov 2009
KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411
K083105 · Bio-Medical Research, Ltd. · Jul 2009
STIWELL MED4
K080950 · Otto Bock, Austria GmbH · Apr 2009
SRT II MUSCLE STIMULATOR
K071677 · Therapeutic Innovations, Inc. · Jul 2008
COMBI 8 MAX
K070888 · Cec Electronica S.R.L. · Jul 2008
K090632 · COMPEX REHAB
Download PDF FDA Summary Chattanooga Group