HIVOX DREAMATE DM-800

K021952 · Hivox Biotek, Inc. · GZJ · May 2, 2003 · Neurology

Device Facts

• Record ID: K021952
• Device Name: HIVOX DREAMATE DM-800
• Applicant: Hivox Biotek, Inc.
• Product Code: GZJ · Neurology
• Decision Date: May 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

used to apply a minor electrical current to electrodes on patient's wrist skin to function as: - Helping relieve nausea and vomiting due to motion sickness.

Device Story

DM-800 is a transcutaneous electrical nerve stimulator (TENS) designed for wrist-worn use. Device applies minor electrical current to electrodes placed on patient's wrist skin. Operation involves delivery of electrical stimulation to target nerves to alleviate symptoms of motion sickness. Intended for over-the-counter use by patients experiencing nausea and vomiting. Device provides non-pharmacological alternative for symptom management.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device classification and intended use.

Technological Characteristics

Transcutaneous electrical nerve stimulator (TENS); wrist-worn form factor; electrical stimulation via skin electrodes; Class II device; 21 CFR 882.5890.

Indications for Use

Indicated for the relief of nausea and vomiting due to motion sickness in patients requiring non-pharmacological intervention.

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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Public Health Service

MAY - 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

HIVOX BIOTEK, Inc. C/O Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, Taiwan, ROC

Re: K021952/S2

Trade/Device Name: DM-800 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: GZJ Dated: March 8, 2003 Received: March 14, 2003

Dear Dr. Jen:

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.

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

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## Page 2 - Dr. Ke-Min Jen

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Mark N Millerm

Celia M. Witten, Ph.D., M.D 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 Statement

Applicant: _HIVQX BIQTEK INC.

510(k) Number ( if known): __________________________________________________________________________________________________________________________________________________

Device Name: HIVOX DM-800_

Indications for use: used to apply a minor electrical current to electrodes on patient's wrist skin to function as:

- Helping relieve nausea and vomiting due to motion sickness. 트
( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE )

Concurrence of CDRH, office of Device Evaluation (ODE )

| Prescription Use | OR | Over - The - Counter - Use_ \u2713 |
|------------------------|----|------------------------------------|
| ( Per 21 CFR 801.109 ) | | ( Optional Format 1-2-96 ) |

for
Mark N Millkenn
(Division Sign-Off)
Division
Restorative
and Neurological Devices

| 510(k) Number_ | K021952 |
|----------------|---------|
|----------------|---------|