(30 days)
Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain.
Interferential Stimulator Model BMLS03-6
The provided text is a 510(k) clearance letter for an Interferential Stimulator, Model BMLS03-6. It states that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot provide the requested table and study description based on the provided text. The document is solely a regulatory clearance letter, not a technical report or study summary.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 2004
Richard Saxon President Biomedical Life Systems, Inc. P.O. Box 1360 Vista, California 92085-1360
Re: K040824
Trade/Device Name: Interferential Stimulator, Model BMLS03-6 Regulation Number: unclassified Regulation Name: Interferential Stimulator Regulatory Class: Unclassified Product Code: LIH Dated: Undated Received: April 9, 2004
Dear Mr. Saxon:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your rocuon 910(x) prodecise is substantially equivalent (for the indications for relered above and have are are and marketed predicate devices marketed in interstate commerce use stated in the encreasury hate of the Medical Device Amendments, or to devices that provi to Nay 26, 1970, the chactinent with the provisions of the Federal Food, Drug, and Cosmetic Act flact) that do not require approval of a premarket approval application (PMA). You may, therefore, (Act) that do not require appreval controls provisions of the Act. The general controls market the act the Act include requirements for annual registration, listing of devices, good provisions of the rectmerate reg, and prohibitions against misbranding and adulteration.
If your device is classificd (see above) into either class II (Special Controls) or class III (PMA), it may it your aceree is oldsmited (oe are to, Existing major regulations affecting your device can be found be subject to such additional connects. Extrains - 3 - 3 - 3 - 3 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 1 - addition, FDA may publish f announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that I tease be advised mat i 27 t ion 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 r coolal statution and regulation but not limited to: registration and listing (21 CFR Part 807); labeling (21 CliR 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 – Mr. Richard Saxon
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter wif and in you to begal finding of substantial equivalence of your device to a legally premarket notification - 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 CFR 1659. Additionally, for questions on the promotion and advertising of your Compliation (1301) 59 - 1 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 vours,
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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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Interferential Stimulator Model BMLS03-6
Indications for Use:
Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21CFR807 Subpart C)
(Please do NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Millman
al. Restorative. and Neurological Devices
510(k) Number K040829
§ 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).