Cleared Traditional

K940301 - COMPEX 2 (FDA 510(k) Clearance)

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

K940301 · Biodex Medical Systems, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
338d
Days
Class 2
Risk

K940301 is an FDA 510(k) clearance for the COMPEX 2. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Biodex Medical Systems, Inc. (Shirley, US). The FDA issued a Cleared decision on December 28, 1994 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Biodex Medical Systems, Inc. devices

Submission Details

510(k) Number K940301 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 24, 1994
Decision Date December 28, 1994
Days to Decision 338 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
223d slower than avg
Panel avg: 115d · This submission: 338d
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 K940301.
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