Cleared Traditional

K023230 - ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 800

K023230 is an FDA 510(k) clearance for ECHOPULSE MUSCLE STIMULATOR SYSTEM, manufactured by Western Clinical Technology Systems, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K023230 · Western Clinical Technology Systems, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
220d
Days
Class 2
Risk

K023230 is an FDA 510(k) clearance for the ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 800. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Western Clinical Technology Systems, Inc. (San Antonio, US). The FDA issued a Cleared decision on May 5, 2003 after a review of 220 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.

FDA 510(k) Submission Details - K023230

510(k) Number K023230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2002
Decision Date May 05, 2003
Days to Decision 220 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
104d slower than avg
Panel avg: 116d · This submission: 220d
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 541
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K023230.
SYS*STIM 208 AND 208A
K031017 · Mettler Electronics Corp. · May 2003
HOME CARE VAREIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-311, HT-311N, HT-312
K022998 · Home Care Technology Co., Ltd. · May 2003
T.E.A.R. TECH3 MODEL #44TT03
K030507 · Vision Quest Industries, Inc. · May 2003
HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-326L
K023001 · Home Care Technology Co., Ltd. · Apr 2003
VECTORSURGE 5 MODEL 470
K030648 · Metron Medical Australia, Pty, Ltd. · Mar 2003
TENSCARE ULTIMA NMS/EMS
K023997 · Tenscare, Ltd. · Mar 2003
K023230 · ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 800
Download PDF FDA Summary Western Clinical Tech…