BIO SPA INTELLIGENT

K992099 · Starbene · IPF · Jan 18, 2002 · Physical Medicine

Device Facts

• Record ID: K992099
• Device Name: BIO SPA INTELLIGENT
• Applicant: Starbene
• Product Code: IPF · Physical Medicine
• Decision Date: Jan 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MUSCLE STIMULATION THERAPY DELIVERED BY THE BIO SPA INTELLIGENT DEVICE IS INDICATED FOR THE FOLLOWING USES : - 1- Relaxation of Muscle Spasm - 2- Prevention or retardation of disuse atrophy - 3- Increasing local blood circulation - 4- Muscle re-education - 5- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis, and - 6- Maintaining or increasing range of motion

Device Story

Bio Spa Intelligent is a powered muscle stimulator. Device delivers electrical stimulation to muscles to induce contraction. Used for relaxation of muscle spasms, prevention of disuse atrophy, increasing local blood circulation, muscle re-education, postsurgical venous thrombosis prevention, and range of motion maintenance. Operated by clinicians in a therapeutic setting. Output consists of electrical pulses applied to patient musculature to achieve therapeutic physiological effects.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered muscle stimulator; electrical stimulation output; Class II device; Product Code IPF.

Indications for Use

Indicated for patients requiring muscle stimulation therapy for relaxation of muscle spasms, prevention/retardation of disuse atrophy, increasing local blood circulation, muscle re-education, prevention of venous thrombosis via immediate postsurgical calf muscle stimulation, and maintaining or increasing range of motion.

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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'JAN 1 8 2002

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Haydee N. Demarco Starbene David Luque 519 Cordoba Cordoba, Argentina

Re: K992099/S4

Trade/Device Name: Bio Spa Intelligent Regulation Number: 21 CFR 890. 5850 Regulation Name: Powered Muscle Stimulators Regulatory Class: Class II Product Code: IPF Dated: November 23, 2001 Received: November 28, 2001

Dear Ms. Demarco:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing 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 be found in the Code of Federal 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all 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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Haydėe N. Demarco

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and no your e FDA finding of substantial equivalence of your device to a legally promated noticated device 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 Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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,

Mark N Millman

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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Page of

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Bio Spa Intelligen +

Indications For Use:

## INDICATIONS FOR USE

## MUSCLE STIMULATION THERAPY DELIVERED BY THE BIO SPA INTELLIGENT DEVICE IS INDICATED FOR THE FOLLOWING USES :

- 1- Relaxation of Muscle Spasm
- 2- Prevention or retardation of disuse atrophy
- 3- Increasing local blood circulation
- 4- Muscle re-education
- 5- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis, and
- 6- Maintaining or increasing range of motion

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Mark N Milherman
Division Sign Off

eral Bastorative Neurological Devices 510(k) Number_