Cleared Traditional

K002339 - AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MODEL TS-140600

K002339 is an FDA 510(k) clearance for AEMS V, manufactured by Apex Medical Corp.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 388-day FDA review.

K002339 · Apex Medical Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
388d
Days
Class 2
Risk

K002339 is an FDA 510(k) clearance for the AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MODEL TS-140600. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Apex Medical Corp. (Shi-Chih, Taipei Hsien, TW). The FDA issued a Cleared decision on August 24, 2001 after a review of 388 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 Apex Medical Corp. devices

FDA 510(k) Submission Details - K002339

510(k) Number K002339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2000
Decision Date August 24, 2001
Days to Decision 388 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
273d slower than avg
Panel avg: 115d · This submission: 388d
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 272
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K002339.
MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
K013771 · Rich-Mar Corp. · Jan 2002
BIO SPA INTELLIGENT
K992099 · Starbene · Jan 2002
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL NMS-DIGITAL
K010749 · Biomedical Life Systems, Inc. · Sep 2001
MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T
K002336 · Apex Medical Corp. · Jul 2001
SMITH & NEPHEW RESTIM
K003596 · Smith & Nephew, Inc. · Jun 2001
VECTORSURGE 5, MODEL VS-500
K002058 · Metron Medical Australia, Pty, Ltd. · May 2001