(182 days)
Not Found
No
The document does not mention AI, ML, or any related concepts like deep learning, neural networks, or training/test sets for algorithms. The description focuses on standard electrical stimulation modalities.
Yes
The device is indicated for therapeutic purposes such as preventing muscle atrophy, increasing range of motion, increasing blood circulation, relieving chronic pain, and managing acute pain.
No
The device description and intended use indicate it is an electrical stimulator for therapeutic purposes (pain relief, muscle stimulation, etc.), not for diagnosing conditions.
No
The device description explicitly states it is a "Combination Electrical Neuromuscular Stimulator, Interferential Stimulator, and Transcutaneous Electrical Nerve Stimulator (TENS), Model BMLS04-1". This indicates a physical hardware device that delivers 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 clearly describes the device as an external electrical stimulator for therapeutic purposes related to muscles and pain management. This involves applying electrical currents to the body, not analyzing samples taken from the body.
- Device Description: The description confirms it's a combination electrical stimulator.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function falls outside of that definition.
N/A
Intended Use / Indications for Use
Muscle Stimulator Mode: External electrical neuromuscular stimulation using biphasic output is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle reeducation; maintaining and increasing the range of motion; increasing local blood circulation and as immediate postsurgical stimulation of calf muscles to prevent venous thrombosis. Interferential Mode: 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. TENS Mode: Transcutaneous Electrical Nerve Stimulation (TENS) is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
Product codes
GZJ, IPF, 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
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Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21CFR807 Subpart C)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 2004
Mr. Gary Bussett Biomedical Life Systems, Inc. 2448 Cades Way P.O. Box 1360 Vista, California 92085
Re: K041388
K041300
Trade/Device Name: Combination Electrical Neuromuscular Stimulator, Interferential Stimulator, and Transcutaneous Electrical Nerve Stimulator (TENS), Model BML $04-1
Regulation Numbers: 21 CFR 890.5850, 882.5890
Regulation Names: Powered muscle stimulator, Transcutaneous electrical nerve stimulator for pain, and inferential current stimulator.
Regulatory Class: II Product Code: GZJ, IPF, LIH Dated: November 12, 2004 Received: November 15, 2004
Dear Mr. Bussett:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass barearon to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of the reserved 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
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Page 2 - Mr. Gary Bussett
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.
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,
Mark N. Mellauson
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 : K041388
Combination Electrical Neuromuscular Stimulator, Interferential Stimulator, and Device Name: Transcutaneous Electrical Nerve Stimulator (TENS), Model BMLS04-1
Indications for Use:
Muscle Stimulator Mode:
External electrical neuromuscular stimulation using biphasic output is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle reeducation; maintaining and increasing the range of motion; increasing local blood circulation and as immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
Interferential Mode:
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.
TENS Mode:
Transcutaneous Electrical Nerve Stimulation (TENS) is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of post-surgical 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
Mad. A. Milluson
. Restorative,
510(k) Number K041388