DERMABIOSAFE

K080298 · Complete Product Resources · GXY · Aug 5, 2008 · Neurology

Device Facts

• Record ID: K080298
• Device Name: DERMABIOSAFE
• Applicant: Complete Product Resources
• Product Code: GXY · Neurology
• Decision Date: Aug 5, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DermaBioSafe Neuro-muscular Electrodes are intended for use as the disposable, conductive adhesive interface between a patient's skin and the Electrical Stimulator. DermaBioSafe Neuro-muscular Electrodes are intended to be used with marketed, Electrical Stimulators i.e. TENS (Transcutaneous Electrical Nerve Stimulation), and EMS (Electrical Muscular Stimulation). These electrodes will include the precaution statement: Federal Law restricts this device to sale by or on the order of a licensed practitioner or therapist.

Device Story

DermaBioSafe Neuro-muscular Electrodes function as a disposable, conductive adhesive interface between patient skin and external electrical stimulators. Device facilitates delivery of TENS or EMS therapy by providing electrical contact. Used in clinical or home settings under direction of licensed practitioner or therapist. No active electronic components; passive interface device.

Clinical Evidence

Bench testing only.

Technological Characteristics

Disposable, conductive adhesive electrode. Passive interface for TENS/EMS devices. Class II, Product Code GXY.

Indications for Use

Indicated for use as a disposable, conductive adhesive interface between patient skin and electrical stimulators (TENS/EMS). Restricted to sale by or on the order of a licensed practitioner or therapist.

Regulatory Classification

Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Submission Summary (Full Text)

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 5 2008

Complete Product Resources % Mr. John Walsh President 92 Argonaut # 200 Aliso Viejo, California 92656

Re: K080298

Trade/Device Name: DermaBioSafe Neuro-Muscular Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Codc: GXY Dated: July 8, 2008 Received: July 11, 2008

Dear Mr. Walsh:

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. Iisting 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 - Mr. John Walsh

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number: (if known)

Device Name: DermaBioSafe Neuro-muscular Electrodes

Indications for Use:

DermaBioSafe Neuro-muscular Electrodes are intended for use as the disposable, conductive adhesive interface between a patient's skin and the Electrical Stimulator. DermaBioSafe Neuro-muscular Electrodes are intended to be used with marketed, Electrical Stimulators i.e. TENS (Transcutaneous Electrical Nerve Stimulation), and EMS (Electrical Muscular Stimulation).

These electrodes will include the precaution statement: Federal Law restricts this device to sale by or on the order of a licensed practitioner or therapist.

Prescription Use X
(Part 21 CFR 801 Subpart D)

AND / OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart C)

Mark McMillan

(Division Sign-Off Division of General, Restorative, and Neurologic 510(k) Number