Cleared Traditional

K973929 - NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM

K973929 is an FDA 510(k) clearance for NEOTONUS MS-101 MAGNETIC MUSCLE STIMULA..., manufactured by Neotonus, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K973929 · Neotonus, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
218d
Days
Class 2
Risk

K973929 is an FDA 510(k) clearance for the NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Neotonus, Inc. (North Attleboro, US). The FDA issued a Cleared decision on May 21, 1998 after a review of 218 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 Neotonus, Inc. devices

FDA 510(k) Submission Details - K973929

510(k) Number K973929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1997
Decision Date May 21, 1998
Days to Decision 218 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
103d slower than avg
Panel avg: 115d · This submission: 218d
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 K973929.
SURGI STIM
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K980040 · Nisha Communication Industries · Jul 1998
HAKOMED ELECDT / PRO ELEDT SERIES
K980892 · Alive, Inc. · May 1998
HAKOMED ELECDT/VACUPULLS
K980958 · Alive, Inc. · May 1998
ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000)
K980346 · Universal Technology Systems, Inc. · Apr 1998