Cleared Special

K033544 - ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607

K033544 is an FDA 510(k) clearance for ELECTRICAL MUSCLE STIMULATOR, manufactured by Everyway Medical Instruments Co.,Ltd. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Special 510(k) pathway after a 30-day FDA review.

K033544 · Everyway Medical Instruments Co.,Ltd · Physical Medicine device
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Dec 2003
Decision
30d
Days
Class 2
Risk

K033544 is an FDA 510(k) clearance for the ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Everyway Medical Instruments Co.,Ltd (Alpharetta, US). The FDA issued a Cleared decision on December 10, 2003 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Everyway Medical Instruments Co.,Ltd devices

FDA 510(k) Submission Details - K033544

510(k) Number K033544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2003
Decision Date December 10, 2003
Days to Decision 30 days
Submission Type Special
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
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 258
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K033544.
BMLS03-3
K033174 · Biomedical Life Systems, Inc. · Jun 2004
CONTROL SOLUTIONS, INC., MODEL CS3102 HVG
K041146 · Control Solutions, Inc. · Jun 2004
HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-7
K040306 · Biomedical Life Systems, Inc. · Mar 2004
NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P
K033140 · Everyway Medical Instruments Co.,Ltd · Oct 2003
AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
K032941 · Rich-Mar Corp. · Oct 2003
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1
K031427 · Biomedical Life Systems, Inc. · Aug 2003