SURETONE

K011588 · Suretone International · IPF · Mar 28, 2002 · Physical Medicine

Device Facts

• Record ID: K011588
• Device Name: SURETONE
• Applicant: Suretone International
• Product Code: IPF · Physical Medicine
• Decision Date: Mar 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The "Surestim" is an electrical powered muscle stimulator used to apply an electrical current through electrodes to a patient's skin for the relaxation of muscle spasms.

Device Story

Surestim is a powered muscle stimulator; applies electrical current to patient skin via electrodes; intended for relaxation of muscle spasms. Device operates as a prescription-use muscle stimulator. Clinical benefit involves non-invasive management of muscle spasms.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered muscle stimulator; electrical stimulation via skin electrodes; Class II device (21 CFR 890.5850); Product Code IPF.

Indications for Use

Indicated for patients requiring relaxation of muscle spasms via electrical stimulation applied through skin electrodes.

Regulatory Classification

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2002

Mrs. Maryna Burke Suretone International 2 President Brand Street Panorama, Cape Town, South Africa 7500

Re: K011588

Trade/Device Name: Surestim Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: January 22, 2002 Received: January 30, 2002

Dear Mrs. Burke:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications forcenous a over and in the enclosure) to legally marketed predicate devices marketed in interstate for use battled in the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 1977, in textordance with the provisions of the Federal Food, Drug, devices that have boon require approval of a premarket approval application (PMA). and Cosmetic For (110) has the device, subject to the general controls provisions of the Act. The r ou may, mererers, mains of the Act include requirements for annual registration, listing of general oonly is free wing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may or subject to dates are as a regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r read ove as note a determination that your device complies with other requirements of the Act that I Drederal statutes and regulations administered by other Federal agencies. You must or any I odotal the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OF R Part 807), adoning (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality byevelles (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 .- Mrs. Burke

This letter will allow you to begin marketing your device as described in your Section 510(k) This iciter witi anow you to oogin mating of substantial equivalence of your device to a legally prematication: "The PDF results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of IC Far 3639. Additionally, for questions on the promotion and advertising of Compliance at (301) 594 - 1 the Office of Compliance at [phone]. Also, please note the your do roo, product of the reference to premarket notification" (21CFR Part 807.97). regulation entires, "Thiss on your responsibilities under the Act may be obtained from the Other general michance turers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

b. Mark M. Millican

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## REVISED INDICATION FOR USE STATEMENT

K011588

510(k) Number (if known):

Surestim

Device Name:

Indication for Use:

The "Surestim" is an electrical powered muscle stimulator used to apply an electrical current through electrodes to a patient's skin for the relaxation of muscle spasms.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ***_*** OR Over-The-Counter Use **_**
(Per 21 CFR 801.109) (Optional Format

Muk N Melku
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number K011588

(Optional Format 1-2-96)