(942 days)
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
Not Found
The provided text is related to an FDA 510(k) clearance for a device called "Bio Spa Intelligent." It does not contain information about acceptance criteria, study design, or performance metrics. The document is a clearance letter and an "Indications For Use" statement.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
'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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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_
§ 890.5850 Powered muscle stimulator.
(a)
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.(b)
Classification. Class II (performance standards).