RELIEFBAND TENS UNIT (MODIFICATION)

K961050 · Maven Labs, Inc. · GZJ · Aug 1, 1997 · Neurology

Device Facts

• Record ID: K961050
• Device Name: RELIEFBAND TENS UNIT (MODIFICATION)
• Applicant: Maven Labs, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Aug 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To reduce the frequency of nausea and vomiting due to chemotherapy, motion sickness, and pregnancy.

Device Story

ReliefBand is a wearable device designed to reduce nausea and vomiting. It operates by delivering electrical stimulation to the median nerve at the wrist (acupressure point P6). The device is worn by the patient and is intended for prescription use. By providing transcutaneous electrical nerve stimulation, it aims to alleviate symptoms of nausea and vomiting caused by chemotherapy, motion sickness, or pregnancy. The healthcare provider prescribes the device, and the patient operates it to manage their symptoms, potentially reducing the need for anti-emetic medications.

Technological Characteristics

Wearable device utilizing transcutaneous electrical nerve stimulation (TENS) to target the median nerve at the wrist. Prescription-use device.

Indications for Use

Indicated for patients experiencing nausea and vomiting associated with chemotherapy, motion sickness, and pregnancy.

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)

{0}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Daniel J. Manelli
for Maven Laboratories, Inc.
Farkas & Manelli, P.L.L.C.
1233 20th Street, N.W., Suite 700
Washington, D.C. 20036

AUG - I 1997

Re: K961050
Trade Name: ReliefBand
Regulatory Class: II
Product Code: 73BWK
Dated: February 6, 1996
Received: February 8, 1996

Dear Mr. Manelli:

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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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.

{1}

Page 2 - Mr. Daniel J. Manelli

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* 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" (21 CFR 807.97). 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,

Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

{2}

Page 1 of 1

510(k) Number (if known): K961050

Device Name: ReliefBand

Indications For Use:

To reduce the frequency of nausea and vomiting due to chemotherapy, motion sickness, and pregnancy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ (Per 21 CFR 801.109)


(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number

(Optional Format 1-2-96)

100

XvJ 01:81 Idd L6/81/20