BMLS16-1

K172971 · Biomedical Life Systems, Inc. · NUH · Jul 8, 2018 · Neurology

Device Facts

• Record ID: K172971
• Device Name: BMLS16-1
• Applicant: Biomedical Life Systems, Inc.
• Product Code: NUH · Neurology
• Decision Date: Jul 8, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The BMLS16-1 Transcutaneous Electrical Nerve Stimulation (TENS) device is used for the symptomatic relief and management of chronic (long-term) intractable pain.

Device Story

BMLS16-1 is a Transcutaneous Electrical Nerve Stimulator (TENS) for chronic, intractable pain management. Device delivers electrical pulses via electrodes to skin surface to stimulate nerves. Intended for over-the-counter (OTC) use by patients for self-administration of therapy. Provides symptomatic relief; does not treat underlying pathology. Operation involves user-controlled settings for pulse parameters to manage pain levels.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use consistent with predicate TENS devices.

Technological Characteristics

Transcutaneous electrical nerve stimulator; delivers electrical pulses via surface electrodes. Class II device (21 CFR 882.5890, Product Code NUH).

Indications for Use

Indicated for symptomatic relief and management of chronic, intractable pain in patients.

Regulatory Classification

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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

July 8, 2018

BioMedical Life Systems, Inc. Gary Bussett Engineer P.O. Box 1360 Vista, California 92085-1360

Re: K172971

Trade/Device Name: BMLS16-1 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: April 5, 2018 Received: April 9, 2018

Dear 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

## Pamela D. Scott -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K172971

Device Name BMLS16-1

Indications for Use (Describe)

The BMLS16-1 Transcutaneous Electrical Nerve Stimulation (TENS) device is used for the symptomatic relief and management of chronic (long-term) intractable pain.

Type of Use (Select one or both, as applicable)

| ☐ Depository Use (31 CFR 331 Subpart D) | ☑ On-Site Contractor Use (31 CFR 331 Subpart C) |
|-----------------------------------------|-------------------------------------------------|
|-----------------------------------------|-------------------------------------------------|

__ Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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