(225 days)
This BIO-STIM KIT is intended for temporary relief of pain associated with sore and aching muscle in the lower back due to strain from exercise or normal household and work activities.
Not Found
This is a scanned FDA 510(k) clearance letter for the "BIO-STM KIT", a transcutaneous electrical nerve stimulator for pain relief. The document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and therefore can be marketed. It does not include performance data or studies.
Therefore, I cannot provide the requested information.
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SEP - 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Betty Chien Regulatory Affairs Skylark Devices & Systems Co., Ltd. 4F 34 SEC. 3 Chung Shan N. Road Taipei. China (Taiwan)
Re: K050174
Trade/Device Name: BIO-STM KIT Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ, NUH Dated: September 2, 2005 Received: September 6, 2005
Dear Ms. Chien:
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 (QS) 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. Betty Chien
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
signature
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: BIO-STIM KIT
Indications for Use:
Indication Use For
This BIO-STIM KIT is intended for temporary relief of pain associated with sore and aching muscle in the lower back due to strain from exercise or normal household and work activities.
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use ______________ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
: CDRH, Office of Device Evaluation (ODE)
(Division Division of General, Restorative, and Neurological Devices
(Posted November 13, 2003)
KOSU 194 510(k) Number_
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).