TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001

K042107 · Tung FU Electric Co., Ltd. · GZJ · Mar 9, 2005 · Neurology

Device Facts

• Record ID: K042107
• Device Name: TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001
• Applicant: Tung FU Electric Co., Ltd.
• Product Code: GZJ · Neurology
• Decision Date: Mar 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

it is used for the symptomatic relief and management of chronic, intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems. Clinical settings: should be used under the instruction or prescriptions by . qualified health professionals prior to the applications of the device at home or hospital facilities.

Device Story

Tung Fu Airmate TENS-Vitality Mode (TF-DT001) is a transcutaneous electrical nerve stimulator; delivers electrical pulses to skin via electrodes to modulate pain signals. Used in home or hospital settings; operated by patients under physician instruction/prescription. Device provides symptomatic relief for chronic, intractable pain and adjunctive management for post-surgical/post-traumatic acute pain. Output affects clinical decision-making by providing non-pharmacological pain management option; benefits patient through potential reduction in pain levels.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Transcutaneous electrical nerve stimulator (TENS); electrical pulse output for pain relief. Class II device (21 CFR 882.5890).

Indications for Use

Indicated for symptomatic relief and management of chronic, intractable pain and adjunctive treatment of post-surgical and post-traumatic acute pain in patients under professional instruction or prescription.

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/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract image of an eagle with three stylized wing segments. The eagle faces to the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 9 - 2005

Tung Fu Electric Co., Ltd. c/o Dr. Jen, Ke-Min ROC Chinese-European Industrial Research Society 58 Fu-Chiun Street Hsin-Chu City, China (Taiwan) 300

Re: K042107

Trade/Device Name: Tung Fu Airmate Tens-Vitality Mode TF-DT001 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief. Regulatory Class: II Product Code: GZJ Dated: December 23, 2004 Received: January 7. 2005

Dear Dr. Jen:

We have reviewed your Scction 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 Acti: 21 CFR 1000-1050,

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Page 2 - Dr. Jen, Ke-Min

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 Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.

Sincercly yours.

Stupt Rhodes

Miriam C. Provost. Ph.D. Acting Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 4. INDICATIONS FOR USE STATEMENT

## Indications for Use

510(k) Number: TBA

TUNG FU AIRMATE TENS – VITALITY MODE Device Name: TF-DT001

Indications For Use:

- Specific indications: it is used for the symptomatic relief and management of chronic, intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
- Clinical settings: should be used under the instruction or prescriptions by . qualified health professionals prior to the applications of the device at home or hospital facilities.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

(Concurrence of Office of Device of Device Evaluation (ODE) Division - Par

and Neuropa

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510(k) Number .