(187 days)
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Not Found
No
The summary describes a standard electrical stimulator and contains no mention of AI, ML, or related concepts.
Yes
The device is used for symptomatic relief and management of chronic pain, intractable pain, and acute pain, which are therapeutic applications.
No
The intended use describes symptomatic relief and management of pain, not diagnosis. This device appears to be for therapeutic stimulation.
No
The device description explicitly states "Interferential Stimulator Model BMLS02-6", which implies a physical hardware device for electrical stimulation, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for pain relief and management through electrical stimulation. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as an "Interferential Stimulator," which is a type of electrical stimulation device.
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device, an Interferential Stimulator, is used to apply electrical currents to the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or musclefitial Olimbiation is used for bymptomatic followical and post-traumatic acute pain.
Product codes
LIH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, which is a common symbol used by the U.S. government.
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
2
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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