Cleared Traditional

K980040 - ELECTRONIC MUSCLE STIMULATOR - MICROSTIM J-1304D

K980040 is an FDA 510(k) clearance for ELECTRONIC MUSCLE STIMULATOR - MICROSTI..., manufactured by Nisha Communication Industries. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K980040 · Nisha Communication Industries · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
189d
Days
Class 2
Risk

K980040 is an FDA 510(k) clearance for the ELECTRONIC MUSCLE STIMULATOR - MICROSTIM J-1304D. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Nisha Communication Industries (Northbridge, US). The FDA issued a Cleared decision on July 13, 1998 after a review of 189 days - an extended review 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: 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 Nisha Communication Industries devices

FDA 510(k) Submission Details - K980040

510(k) Number K980040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1998
Decision Date July 13, 1998
Days to Decision 189 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
74d slower than avg
Panel avg: 115d · This submission: 189d
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 K980040.
HANDMASTER NMS1
K982482 · N.E.S.S. Nuromuscular Electrical Stimulation Syst · Sep 1998
SURGI STIM
K982388 · Vision Quest Industries, Inc. · Sep 1998
MYO-TRAIN V (5)
K980158 · Sterne Equipment Co., Ltd. · Jul 1998
NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM
K973929 · Neotonus, Inc. · May 1998
HAKOMED ELECDT / PRO ELEDT SERIES
K980892 · Alive, Inc. · May 1998
HAKOMED ELECDT/VACUPULLS
K980958 · Alive, Inc. · May 1998