Cleared Traditional

K982482 - HANDMASTER NMS1

K982482 is an FDA 510(k) clearance for HANDMASTER NMS1, manufactured by N.E.S.S. Nuromuscular Electrical Stimulation Syst. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K982482 · N.E.S.S. Nuromuscular Electrical Stimulation Syst · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
76d
Days
Class 2
Risk

K982482 is an FDA 510(k) clearance for the HANDMASTER NMS1. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by N.E.S.S. Nuromuscular Electrical Stimulation Syst (Washington, US). The FDA issued a Cleared decision on September 30, 1998 after a review of 76 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.

View all N.E.S.S. Nuromuscular Electrical Stimulation Syst devices

FDA 510(k) Submission Details - K982482

510(k) Number K982482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1998
Decision Date September 30, 1998
Days to Decision 76 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
39d faster than avg
Panel avg: 115d · This submission: 76d
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 K982482.
SYS STIM 294, MODEL ME 294
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SONICATOR PLUS 992, MODEL NUMBER ME 992 AND SONICATOR PLUS 994, MODEL NUMBER ME 994
K984142 · Mettler Electronics Corp. · Feb 1999
FORTE, MODELS CPS 400 STIM, CPS 200 STIM
K982828 · Chattanooga Group, Inc. · Nov 1998
SURGI STIM
K982388 · Vision Quest Industries, Inc. · Sep 1998
MYO-TRAIN V (5)
K980158 · Sterne Equipment Co., Ltd. · Jul 1998
ELECTRONIC MUSCLE STIMULATOR - MICROSTIM J-1304D
K980040 · Nisha Communication Industries · Jul 1998