Cleared Traditional

K840346 - NEUROMUSCLAR II (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K840346 · Mentor Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1984
Decision
15d
Days
Class 2
Risk

K840346 is an FDA 510(k) clearance for the NEUROMUSCLAR II. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Mentor Corp. (Walker, US). The FDA issued a Cleared decision on February 10, 1984 after a review of 15 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 Mentor Corp. devices

Submission Details

510(k) Number K840346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1984
Decision Date February 10, 1984
Days to Decision 15 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 115d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 544
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K840346.
Compact II
K251083 · Enraf-Nonius, B.V. · Sep 2025
EVE Synergy (EVE-20M)
K241433 · Weero Co., Ltd. · Jun 2025
TrainFES Advance
K241488 · Trainfes · Feb 2025
Quantum Mitohormesis (QMT) (M2101)
K240348 · Quantumtx Pte. , Ltd. · Dec 2024
eMVFit (MVF-10M)
K240992 · Weero Co., Ltd. · Oct 2024
BTL-899MS
K240234 · BTL Industries, Inc. · Aug 2024