(149 days)
For the relief of nausea. Nausea may be caused by motion, morning sickness, chemotherapy or anesthesia.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for the "Ezy-Travel Wristbands," an acupressure device. This letter indicates a finding of substantial equivalence to a legally marketed predicate device for the stated indications for use (relief of nausea).
However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for the device. The letter solely states that the device is substantially equivalent and can be marketed.
Therefore, I cannot provide the requested information from the given text. The document does not describe the acceptance criteria or a study that proves the device meets them.
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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.
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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
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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
N/A