RELIEFBAND MST DEVICE, MODELS RB-2, RB-6, RB-R

K982967 · Woodside Biomedical, Inc. · GZJ · Feb 23, 1999 · Neurology

Device Facts

• Record ID: K982967
• Device Name: RELIEFBAND MST DEVICE, MODELS RB-2, RB-6, RB-R
• Applicant: Woodside Biomedical, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Feb 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ReliefBand® Device is indicated for the relief of nausea and vomiting (NV) due to motion sickness

Device Story

ReliefBand® (Models RB-2, RB-6, RB-R) is a transcutaneous electrical nerve stimulation (TENS) device. It delivers electrical pulses to the median nerve at the wrist to treat nausea and vomiting associated with motion sickness. The device is worn on the wrist like a watch; it is intended for over-the-counter (OTC) use by patients. By stimulating the median nerve, the device modulates neural pathways involved in the emetic reflex, providing symptomatic relief without pharmacological agents. Patients operate the device by adjusting stimulation intensity to achieve the desired therapeutic effect.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Transcutaneous electrical nerve stimulation (TENS) device; wrist-worn form factor; electrical pulse output for median nerve stimulation.

Indications for Use

Indicated for 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 1999

Ms. Carol L. Patterson Consultant for Woodside Biomedical, Inc. Patterson Consulting Group, Inc. 18140 Smokesignal Drive San Diego, California 92127

Re: K982967 ReliefBand® NST™ Device, Trade Name: Models RB-2, RB-6, and RB-R Regulatory Class: II Product Code: GZJ November 24, 1998 Dated: Received: November 25, 1998

Dear Ms. Patterson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Carol L. Patterson

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diaqnostic 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" (21 CFR 807.97). Other gener Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director

Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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WOODSIDE BIOMEDICAI., INC. RELIEFBAND® DEVICE OTC 510K

## OTC INDICATIONS FOR USE

| 510(k) Number: | K982967<br>(To Be Assigned By FDA) |
|----------------------|----------------------------------------------------------------------------------------------------------|
| Device Name: | ReliefBand® Device Models RB-2, RB-6, and<br>RB-R |
| Indications For Use: | The ReliefBand® Device is indicated for the relief of<br>nausea and vomiting (NV) due to motion sickness |

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 Devices | |
| 510(k) Number | K982967 |

OR Prescription Use Over-The-Counter Use (Per 21 CFR 801.109)