COMBOCARE 2000

K083202 · Xanacare Technologies, LLC · GZJ · Dec 15, 2008 · Neurology

Device Facts

• Record ID: K083202
• Device Name: COMBOCARE 2000
• Applicant: Xanacare Technologies, LLC
• Product Code: GZJ · Neurology
• Decision Date: Dec 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ComboCare 2000 is intended for the temporary relief of minor muscle and joint pain, promoting the relaxation of muscle tissue, temporarily increasing local blood circulation, symptomatic relief and management of chronic intractable pain, and adjunctive relief of postsurgical or post-traumatic acute pain.

Device Story

ComboCare 2000 is a therapeutic device providing transcutaneous electrical nerve stimulation (TENS), infrared heat, and static magnetic field therapy. Device utilizes flexible pads containing permanent magnets and infrared light sources to deliver therapeutic heating and magnetic fields alongside electrical stimulation. Operated by trained personnel in clinical settings for pain management. Output consists of electrical pulses, infrared heat, and static magnetic fields applied to the patient's skin. These modalities aim to promote muscle relaxation, increase local blood circulation, and provide symptomatic relief for chronic or acute pain. Device design incorporates risk management per ISO 14971 to mitigate hazards.

Clinical Evidence

No clinical data. Substantial equivalence determined via non-clinical bench testing and design validation against specified requirements and voluntary standards (EN 60601-1, EN 60601-1-2, EN 60601-2-10).

Technological Characteristics

Device combines TENS, infrared heating, and static magnetic field therapy. Components include flexible pads with integrated permanent magnets and infrared light sources. Complies with EN 60601-1 (general safety), EN 60601-1-2 (EMC), and EN 60601-2-10 (nerve/muscle stimulators). Risk management follows ISO 14971.

Indications for Use

Indicated for temporary relief of minor muscle and joint pain, muscle relaxation, increased local blood circulation, management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic acute pain.

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

• ComboCare 2000 (K081141)
• TerraQuant MQ2000 v.5 with TQ-ITENS (K071445)

Submission Summary (Full Text)

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DEC 1 5 2008

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510(k) Number:

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Date: .

# 510(k) Summary

#### Introduction

This summary is intended to comply with requirements of the SMDA and 21CFR 807.92. FDA may make this summary available to the public within 30 days following a finding of substantial equivalence.

#### 510(k) Applicant

Xanacare Technologies LLC 9185 East Kenyon Ave., Ste. 270 Denver, CO 80237 USA Tel: [phone] / Fax: [phone]

#### 510(k) Correspondent

Robert N. Clark, President and Senior Consultant Medical Device Regulatory Advisors, Inc. 13605 West 7th Ave., Golden, CO 80401 USA Tel: [phone] / Fax: [phone]

#### Date Prepared

October 24, 2008

#### Trade Name of Device

ComboCare 2000

#### Classification Name

Transcutaneous electrical nerve stimulator for pain relief

#### 510(k) Classification

Class II

#### Predicate Devices

The ComboCare 2000 has technological characteristics similar to the following predicate device(s):

- K081141 Xanacare Technologies LLC ComboCare 2000 .
- K071445 Escada International, Inc. TerraQuant MQ2000 v.5 with TQ-ITENS .

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Date:

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### Device Description and Intended Use

This device, modified from the ComboCare 2000 device previously cleared under 510(k) K081141, includes the addition of permanent magnets to the flexible pads to create a static magnetic field and increased Infrared light strength for therapeutic heating.

The ComboCare 2000 is intended for the temporary relief of minor muscle and joint pain, promoting the relaxation of muscle tissue, temporarily increasing local blood circulation, symptomatic relief and management of chronic intractable pain, and adjunctive relief of postsurgical or post-traumatic acute pain.

## Clinical & Non-Clinical Testing

Xanacare did not conduct, nor rely upon, clinical tests to determine substantial equivalence. Nonclinical testing was performed in order to validate the design against the company's specified design requirements, and to assure conformance with the following voluntary design standards:

- EN 60601-1 "Medical electrical equipment Part 1: General requirements for safety". .
- EN 60601-1-2 "Medical electrical equipment Part 1-2: General requirements for safety -� Collateral Standard"
- EN 60601-2-10 "Medical electrical equipment Part 2: Particular requirements for the . safety of nerve and muscle stimulators"

## Risk Management

This device has been designed to either completely eliminate or mitigate known health hazards associated with the use of the device. Health hazard risk reduction has been accomplished by rigorous application of a risk management program according to standard ISO 14971.

## Substantial Equivalence

Based on the above Xanacare Technologies LLC believes that the ComboCare 2000 is safe and effective when used as instructed by knowledgeable and trained personnel, and is substantially equivalent to the legally marketed predicate device(s).

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### DEC 1 5 2008

Xanacare Technologies, LLC. % Medical Device Regulatory Advisors, Inc Mr. Robert Clark 13605 West 7th Avenue Golden, Colorado 80401

Re: K083202

Trade Name: ComboCare 2000 Regulation Number: 21 CFR 882.5890 Regulation Names: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ, ILY, ISA Dated: November 21, 2008 Received: November 25, 2008

Dear Mr. Clark:

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 -- Mr. Robert Clark

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 the reporting 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 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

083202

510(k) Number (if known):

Device Name:

ComboCare 2000

Indications for Use:

The ComboCare 2000 is intended for the temporary relief of minor muscle and joint pain, promoting the relaxation of muscle tissue, temporarily increasing local blood circulation, symptomatic relief and management of chronic intractable pain, and adjunctive relief of post-surgical or post-traumatic acute pain.

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

**510(k) Number** k083202

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