(84 days)
Not Found
Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, or related concepts, and the device description is not available.
Yes
The device is used for "symptomatic relief and management of chronic (long-term) intractable pain" and as an "adjunctive treatment in the management of post-surgical and post-taumatic acute pain problems," which indicates a therapeutic purpose.
No
The device is described as a Transcutaneous Electrical Nerve Stimulation (TENS) device used for symptomatic pain relief and management. This indicates a therapeutic or treatment function, not a diagnostic one.
Unknown
The provided 510(k) summary lacks a device description, which is crucial for determining if the device is software-only or includes hardware components. The intended use describes a TENS device, which typically involves hardware for electrical stimulation. Without a device description, it's impossible to confirm if this specific device is a software-only implementation or a traditional hardware-based TENS device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a Transcutaneous Electrical Nerve Stimulation (TENS) device used for pain relief. This is a therapeutic application, not a diagnostic one.
- Lack of Diagnostic Activity: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of a TENS device involves applying electrical stimulation to the skin, which is not a diagnostic activity on a specimen.
- No Mention of Specimens or Analysis: The provided text does not mention the collection or analysis of any biological specimens.
Therefore, based on the intended use and the nature of a TENS device, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Transcutaneous Electrical Nerve Stimulation (TENS) devices are 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-taumatic acute pain problems.
Product codes
GZJ
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
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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
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "HUMAN SERVICES USA" and "DEPARTMENT OF" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
ublic Health Service
NOV 1 9 2002
od and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Mr. Richard Saxon President BioMedical Life Systems, Inc. P.O. Box 1360 Vista, CA 92085
Re: K022841 Trade/Device Name: Electro-Nerve Stimulator TENS Model BMLS02-9 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: July 26, 2002 Received: August 27, 2002
Dear Mr. Saxon:
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 (OS) 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. Richard Saxon
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- 4659. Additionally, for questions on the promotion and advertising of your device, please contact the 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,
le 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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ATTACHMENT VII
Page T
| 510(k) Number (if known): | K022841 |
|---|---|
| Device Name: | (TENS) Transcutaneous Electrical Nerve Stimulator |
| For Pain Relief - Class II | |
| Model BMLS02-9 | |
| Indications for Use: | Transcutaneous Electrical Nerve Stimulation (TENS) devices are 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-taumatic acute pain problems. |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark N Mulker
I Restorative and Neurology
510(k) No...
(Optional Format 3-10-98)