(187 days)
Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or intractable pain and as an adjunct in the management of post-surgical and post-traumatic acute pain.
Interferential Stimulator Model BMLS02-6
This is an FDA 510(k) clearance letter for an Interferential Stimulator, Model BMLS02-6. This type of document does not contain the detailed study information or acceptance criteria you are requesting.
FDA clearance letters typically:
- State that the device has been found substantially equivalent to a predicate device.
- List the device name, regulation number, and product code.
- Specify the indications for use.
- Refer to general controls and applicable regulations.
They do not include:
- Specific acceptance criteria for performance.
- Results of studies proving the device meets those criteria (e.g., performance tables, sample sizes, expert qualifications, ground truth methods, MRMC studies, standalone performance).
- Details about training sets or how their ground truth was established.
To find the information you are looking for, you would typically need to consult the full 510(k) summary, clinical study reports, or other design control documents submitted to the FDA, which are generally not part of the publicly released clearance letter.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 7 2004
Richard Saxon President Biomedical Life Systems, Inc. P.O. Box 1360 Vista, California 92085-1360
Re: K040007
Trade/Device Name: Interferential Stimulator, Model BMLS02-6 Regulation Number: Unclassified Regulation Name: Interferential stimulator Regulatory Class: Unclassified Product Code: LIH Dated: June 17, 2004 Received: June 18, 2004
Dear Mr. Saxon:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovened your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass sured in the encreated of the enactment date of the Medical Device Amendments, or to eoniner of the ria) 2011-11-11 in accordance with the provisions of the Federal Food, Drug, de nees mat have been require approval of a premarket approval application (PMA). and coometre fore, market the device, subject to the general controls provisions of the Act. The I ou may) ateres, 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 - Richard Saxon
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter with and by of substantial equivalence of your device of your device to a legally premaince motive 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 11 you a sen o spee of Compliance at (301) 594-4659. 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 Marce facturers, 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,
Miriam C. Provost
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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510(k) Number (if known):
Device Name:
Interferential Stimulator Model BMLS02-6
Indications for Use:
Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or mierelefitial Olimbiation is used for bymptomatic followical 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)
Muriam C. Provost
Division of General, Restorative, and Neurological Devices
510(k) Number K040007
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§ 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).