DX6605E-TENS, DX6605E-G, DX6609-G

K082057 · Shenzhen Dongdixin Technology Co., Ltd. · GZJ · Feb 26, 2009 · Neurology

Device Facts

• Record ID: K082057
• Device Name: DX6605E-TENS, DX6605E-G, DX6609-G
• Applicant: Shenzhen Dongdixin Technology Co., Ltd.
• Product Code: GZJ · Neurology
• Decision Date: Feb 26, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

This device is a prescription device and only for symptomatic relief of chronic intractable pain.

Device Story

Transcutaneous Electrical Nerve Stimulator (TENS) device; battery-powered; delivers square wave pulsed energy via body-surface electrodes. Patient-operated; software-controlled application modes. Output limited by design to prevent hazardous energy delivery. Used for symptomatic relief of chronic intractable pain. Healthcare provider prescribes device for patient use.

Clinical Evidence

Bench testing only. Compliance with IEC60601-1-2 (electrical immunity), EN55011, EN6100-3-3, ISO10993 (biocompatibility), and AAMI/ANSI NS-4 (product performance) standards.

Technological Characteristics

Battery-powered TENS; square wave pulsed energy output; software-controlled application modes; electrodes for body surface application. Complies with IEC60601-1-2, EN55011, EN6100-3-3, ISO10993, and AAMI/ANSI NS-4 standards.

Indications for Use

Indicated for symptomatic relief of chronic intractable pain in patients requiring prescription-based TENS therapy.

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

• GEM-TWIN TENS, Miodel GM3XY/Z (GM320PT) (K042559)

Submission Summary (Full Text)

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K082057

# 510(k) Summary of Safety and Effectiveness

FEB 2 6 2009

## Submitter

Company Name: ShenZhen Dongdixin Technology Co., Ltd. Company Contact: Zhigang Zhao Date Summary Prepared: January 16, 2009

### Device Name

| Trade Name: | DX6605E-G, DX6609-G |
|----------------------|--------------------------------------------|
| Common Name: | TENS |
| Classification Name: | Transcutaneous Electrical Nerve Stimulator |
| Classification: | Class II |

## Predicate Devices (Legally Marketed Devices)

- The predicate device for the DX6605E-G and DX6609-G is the GEM-TWIN TENS, Miodel GM3XY/Z (GM320PT) manufactured by Genmore Technology Company, LTD. The 510(k) registration number is K042559.
## Device Description

The device is a Transcuteneous Electrical Nerve Stimulator. This devices utilizes battery power to produce square wave pulsed energy through electrodes placed on the body. The device has multiple modes of application, which are software controlled by the patient. The outputs are limited by design, so that hazardous energy cannot be delivered to the patient.

#### Intended Use

The purpose and function of the DX6605E-G, DX6609-G device is as follows:

This device is a prescription device and only for symptomatic relief of chronic intractable pain. . Summary of Technical Characteristics of the Device Compared to the Predicate Davices (Legally Marketed Devices)

Summary of Performance Testing: The DX6609-G (representative of the DX6605E-G) Series 2:1005 LA1 2001 Co Flast of IEC60601-1-2 2nd edition, EN55011:1998+A2:2002, EN6100-3-3:1995+A1:2001 for Electrical Immunity. The device accessories were tested to ISO10933 parts 5 100 10 10 100 100 100 100 100 1000 1000 100 1000 1000 1000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 10.10971 At 2012 10:1987+A1: 2001 and AAMI/ANSI NS-4 for product performance. The device compliss with all requirements of these standards.

#### Conclusions

As stated above, the DX6605E-G and DX6609-G are safe and effective, comply with the appropriate medical device standards, and are substantially equivalent to the earlier identified predicate devices.

- End of Section -

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with its wings spread, overlaid on a circular seal. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged around the top of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shenzhen Dongdixin Technology Co., Ltd. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, NW Buffalo, Minnesota 55313

FEB 2 6 2009

Re: K082057

Trade Name: DX6605E-G and DX6609-G Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: February 10, 2009 Received: February 11, 2009

Dear Mr. Job:

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. Mark Job

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 the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkersen 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: DX6605E-G and DX6609-G

## Indications For Use:

This device is a prescription device and only for symptomatic relief of chronic intractable 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) Page 1 of 1

R/

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

**510(k) Number** k082057