Cleared Traditional

K021905 - CLASSIC NMS

K021905 is an FDA 510(k) clearance for CLASSIC NMS, manufactured by Care Rehab, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K021905 · Care Rehab, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
87d
Days
Class 2
Risk

K021905 is an FDA 510(k) clearance for the CLASSIC NMS. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Care Rehab, Inc. (Mclean, US). The FDA issued a Cleared decision on September 5, 2002 after a review of 87 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 - K021905

510(k) Number K021905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2002
Decision Date September 05, 2002
Days to Decision 87 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
29d faster than avg
Panel avg: 116d · This submission: 87d
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 537
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K021905.
EMS 400
K022493 · Body Clock Health Care, Ltd. · Oct 2002
NESS SYSTEM
K022776 · Ness-Neuromuscular Electrical Stimulation Systems · Sep 2002
P4 PHYSIO
K022175 · Valmed Corp. · Sep 2002
HMS-DHR-3 NEUROMUSCULAR STIMULATOR
K021472 · Home Medical Services · Aug 2002
NEUROTECH MEDISTIM PLUS, TYPE 291
K014019 · Bio-Medical Research, Ltd. · Jul 2002
POWERED MUSCLE STIMULATOR
K013768 · Theratech, Inc. · Jul 2002
K021905 · CLASSIC NMS
Download PDF FDA Summary Care Rehab, Inc.