INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE

K070217 · Neuro Resource Group, Inc. · NFO · Apr 4, 2008 · Neurology

Device Facts

• Record ID: K070217
• Device Name: INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE
• Applicant: Neuro Resource Group, Inc.
• Product Code: NFO · Neurology
• Decision Date: Apr 4, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended for cosmetic use.

Device Story

InterX 1000/Derma 200 is a hand-held, battery-operated transcutaneous electrical nerve stimulator. Device consists of main operating unit (InterX 1000) and external electrode (Derma 200). Used for cosmetic applications. Operation involves applying electrical stimulation via external electrode to target areas. Intended for use by consumers/patients for cosmetic purposes. Output is electrical stimulation; intended to provide cosmetic benefits. Device design is based on previously cleared electrical stimulation technology.

Clinical Evidence

Bench and clinical testing were conducted to demonstrate performance for the device's intended use. Compliance with 21 CFR 898.12 for patient lead wires and electrodes was verified.

Technological Characteristics

Hand-held, battery-operated transcutaneous electrical nerve stimulator. Includes main unit and external electrode. Complies with 21 CFR 898.12 performance standards for lead wires and electrodes.

Indications for Use

Indicated for cosmetic use. No specific patient population, age, or disease state defined.

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.

Predicate Devices

• InterX 5000 (K042912)
• Rejuvenique (K011935)
• Salton Facemaster of Beverly Hills Facemaster (K040871)

Submission Summary (Full Text)

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# Section 5 - 510(k) Summary

Submitter Information Neuro Resource Group, Inc. 1100 Jupiter Road, Suite 190 Plano, TX 75074 Establishment Registration # 3004786509

APR - 4 2008

### Contact

Krista Oakes, Vice President of Regulatory Affairs Telephone: [phone] Fax: [phone] Email: [e-mail]

Date Prepared April 3, 2008

Product Name InterX 1000/Derma 200 Stimulator for Cosmetic Use

#### Predicate Devices

Manufacturer 510k Reference Device Neuro Resource Group K042912 InterX 5000 K011935 Rejuvenique Salton Facemaster of Beverly Hills K040871 Facemaster

#### Product Description

The InterX 1000/Derma 200 Stimulator for Cosmetic Use is a hand-held, battery operated device consisting of a main operating unit (InterX 1000) and an external electrode (Derma 200).

Intended Use This device is intended for cosmetic use.

## Comparison to Predicate Device

This device is equivalent in technology to the InterX 5000 device, currently marketed by our firm under K042912, with changes to accommodate new indications for cosmetic use. These indications are equivalent to devices cleared under K040871 and K011935.

#### Performance Testing & Conclusions

This device complies with performance standard requirements (21 CFR 898.12) relating to patient lead wires and electrodes. Bench and clinical testing were conducted to demonstrate performance for the device's intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Neuro Resource Group, Inc. % Ms. Krista Oakes Vice President, Regulatory Affairs 1100 Jupiter Road, Suite 190 Plano, Texas 75074

APR - 4 2008

Re: K070217

Trade Name: InterX 1000 Stimulator/Derma 200 Electrode for Cosmetic Use Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code NFO, GXY Dated: January 4, 2008 Received: January 7, 2008

Dear Ms. Oakes:

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.

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Page 2 - Ms. Krista Oakes

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 [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millerson

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:

Device Name: InterX 1000/Derma 200 Stimulator for Cosmetic Use

Indications for Use:

This device is intended for cosmetic use.

Prescription Use XX (Part 21 CFR 801 Subpart D)

AND/OR

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

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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. P. Boyle-Gorman

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** K070217