Cleared Special

K033140 - NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P

K033140 is an FDA 510(k) clearance for NEUROMUSCULAR ELECTRICAL 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 29-day FDA review.

K033140 · Everyway Medical Instruments Co.,Ltd · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
29d
Days
Class 2
Risk

K033140 is an FDA 510(k) clearance for the NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P. 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 October 29, 2003 after a review of 29 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.

FDA 510(k) Submission Details - K033140

510(k) Number K033140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2003
Decision Date October 29, 2003
Days to Decision 29 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
87d faster than avg
Panel avg: 116d · This submission: 29d
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 547
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K033140.
BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580
K031375 · Besmed Health Business Corp · Nov 2003
ELECTRONIC MUSCLE MASSAGE, MODELS BE-550 AND BE-660
K031820 · Multinational · Nov 2003
HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-329M SERIES
K023000 · Home Care Technology Co., Ltd. · Oct 2003
AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
K032941 · Rich-Mar Corp. · Oct 2003
RHYTHM TOUCH Q 2-WAY
K032178 · Shockim Enterprises, Ltd. · Oct 2003
MEDRELIEF SE SERIES, MODELS SE-50, SE-100, SE-200, SE-300
K030998 · Healthonics, Inc. · Oct 2003
K033140 · NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P
Download PDF FDA Summary Everyway Medical Inst…