← Product Code MVV · K041766 # EZY-TRAVEL WRISTBAND (K041766) _Apothecary Products, Inc. · MVV · Nov 26, 2004 · NE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K041766 ## Device Facts - **Applicant:** Apothecary Products, Inc. - **Product Code:** MVV - **Decision Date:** Nov 26, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** NE - **Attributes:** Therapeutic ## Indications for Use For the relief of nausea. Nausea may be caused by motion, morning sickness, chemotherapy or anesthesia. ## Device Story Ezy-Travel Wristband is an acupressure device designed to alleviate nausea. It functions by applying mechanical pressure to specific acupressure points on the wrist. The device is intended for use by patients experiencing nausea due to motion, pregnancy (morning sickness), chemotherapy, or anesthesia. It is a non-invasive, wearable product used for self-care in home or travel settings. By providing continuous pressure, it aims to provide symptomatic relief without the use of medication. ## Clinical Evidence No clinical data provided; substantial equivalence based on historical marketing status of similar acupressure devices. ## Technological Characteristics Mechanical acupressure device; wearable wristband form factor; non-powered; non-invasive; no software or electronic components. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 2 6 2004 Mr. David Kramer Apothecary Products, Inc. 11750 12" Avenue South Burnsville, MN 55337 Re: K041766 Trade Name: Ezy-Travel Wristbands Regulatory Name: Acupressure Device Regulatory Class: Unclassified Product Code: MVV Dated: October 29, 2004 Received: November 12, 2004 Dear Mr. Kramer: 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. {1}------------------------------------------------ ## Page 2 - Mr. David Kramer 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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely vours. Sincerely yours, -Mark A. Mellman 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 {2}------------------------------------------------ ## Indications for Use K041766 510(k) Number (if known): EZY-TRAVEL WRISTBAND Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use: For the relief of nausea. Nausea may be caused by motion, morning sickness, chemotherapy or anesthesia. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use x (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) for (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number K041766 --- **Source:** [https://fda.innolitics.com/device/K041766](https://fda.innolitics.com/device/K041766) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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