(165 days)
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No
The document describes a combination electrical stimulator with various modes (TENS, Muscle Stimulator, Interferential, High Volt Pulsed). There is no mention of AI, ML, or any related concepts in the intended use, device description, or other sections.
Yes
The device is described as having modes for TENS, muscle stimulation, interferential stimulation, and high volt pulsed current stimulation, all of which are indicated for therapeutic purposes such as pain relief, muscle relaxation, muscle reeducation, and prevention of disuse atrophy.
No
Explanation: The Intended Use/Indications for Use and Device Description sections explicitly state that this device is a stimulator used for pain relief, muscle stimulation, and management of various conditions, none of which involve diagnostics. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is a "Combination Transcutaneous Electrical Nerve Stimulator for Pain Relief, Powered Electrical Muscle Stimulator, Interferential Muscle Stimulator, and High Volt Pulsed Stimulator Model BMLS03-7". This indicates a physical 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 uses described (pain relief, muscle stimulation, etc.) are all related to treating or managing conditions within the body using electrical stimulation applied externally.
- Device Description: The device is described as a "Transcutaneous Electrical Nerve Stimulator," "Powered Electrical Muscle Stimulator," etc., which are all types of devices that interact with the body directly, not with samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing 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 does not fit that description.
N/A
Intended Use / Indications for Use
(TENS) Transcutaneous Electrical Nerve Stimulator Mode: Transcutaneous Electrical Nerve Stimulation (TENS) is used for the symptomatic relief and management of chronic (long-term) intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems.
Muscle Stimulator Mode: External electrical neuromuscular stimulation using biphasic output is indicated as therapeutic adjunct for: relaxation of muscle spasm; muscle re-education; prevention of or retardation of disuse atrophy; maintaining and increasing the range of motion; and as immediate post-surgical 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 post-surgical and post-traumatic acute pain.
High Volt Pulsed Current Stimulator Mode: High Voltage Pulsed Stimulation is indicated as therapeutic adjunct for: prevention of or retardation of muscle disuse atrophy, relaxation of muscle spasm, muscle re-education, maintaining and increasing the range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Product codes
IPF, GZJ, 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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2005
Mr. Gary Bussett Biomedical Life Systems, Inc. P.O. Box 1360 Vista, California 92085
Re: K042711
Trade/Device Name: Combination Transcutaneous Electrical Nerve Stimulator for Pain Relief, Powered Electrical Muscle Stimulator, Interferential Muscle Stimulator, and High Volt Pulsed Stimulator Model BMLS03-7 Regulation Numbers: 21 CFR 890.5850, 882.5890 Regulation Names: Powered muscle stimulator, Transcutaneous electrical nerve stimulator for pain relief, and interferential current stimulator. Regulatory Class: II Product Code: IPF, GZJ, LIH Dated: February 23, 2005 Received: February 25, 2005
Dear Mr. Gary Bussett:
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.
1
Page 2 – Mr. Gary Bussett
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icter will anow you to ough finding of substantial equivalence of your device to a legally prematics notification: "The Pro on 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 If you desire specific advision at (240) 276-0120 . Also, please note the regulation entitled, Colliact the Office of Compullinemarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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/industry/support/index.html.
Sincerely yours,
L. Marlin A. Millikenn
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
STATEMENT OF INDICATIONS FOR USE
KOYZZIL
510(k) Number (if known):
Device Name: Combination Transcutaneous Electrical Nerve Stimulator for Pain Relief, Powered Electrical Combination Transculatiedus Liectivel Norvo Gilhalator North Stimulator, Model BML S03-7
Indications for Use:
(TENS) Transcutaneous Electrical Nerve Stimulator Mode:
Transcutaneous Electrical Nerve Stimulation (TENS) is used for the symptomatic relief and management of nort surgical and Transcutaneous Electived Nerve Stimulation (TENO) is about the Symbon.
chronic (long-term) intractable pain and as an adjunctive treatment in the management of post-surgical post-traumatic acute pain problems.
Muscle Stimulator Mode:
External electrical neuromuscular stimulation using biphasic output is indicated as therapeutic adjunct for: External electrical neuromuscular sumulation asing expractic e a pasm; muscle reculture, prevention of relariation of muscle disuse atrophy, roluxation of model of model on and as immediate mailitaining and increasing the range of event venous thrombosis.
Interferential Mode:
Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or as an Interential Summation is used for Symptomation rates and post-fraumatic acute pain.
High Volt Pulsed Current Stimulator Mode:
High Voltage Pulsed Stimulation is indicated as therapeutic adjunct for: prevention of muscle of High Voltage Pulsed Stimulation is Indicated as moralisation maintaining and increasing the range of disuse attophy, relaxation of muscle spash, music roodbated manaly and muscles to prevent venous thrombosis.
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. Wilkerson
510(k) Number K042711