(88 days)
Not Found
No
The device description and performance studies indicate a simple mechanical device that applies pressure, with no mention of AI/ML terms or data processing.
Yes
The device is intended for the relief of nausea, which is a medical condition, and operates by applying pressure to an acupressure point. This falls under the definition of a therapeutic intervention.
No
The device is intended for the relief of nausea by applying pressure to an acupressure point, not for diagnosing any medical condition.
No
The device description explicitly states the product comprises a pair of wristbands with a button, indicating it is a physical device and not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the relief of nausea by applying pressure to an acupressure point. This is a physical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a wristband with a button designed to apply pressure. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or laboratory procedures.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Acu-Strap™ Travel and Motion Sickness Band is intended for the relief of nausea. Nausea may be experienced due to Travel (Motion Sickness), Pregnancy (Morning Sickness), Anesthesia or Chemotherapy.
Product codes
MVV
Device Description
The Acu-Strap™ Travel and Motion Sickness Band product comprises a pair of wristbands, each with a round button added to the interior face of the band. Because the Acu-Strap™ Travel and Motion Sickness Band is stretchable, it will be sold in only one size. The Acu-Strap™ Travel and Motion Sickness Band operates by placing a constant pressure on an acupressure point (the P6 or "Nei-Kuan" point) near the wrist.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
near the wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Acu-Strap™ Travel and Motion Sickness Band has been subjected to testing for dimensions, elasticity, and relative pressure.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
OCT 8 - 2004
510(k) Summary for Acu-Strap™ Travel and Motion Sickness Band K041877
1. SPONSOR
Health Enterprises, Incorporated 90 George Leven Drive North Attleboro, MA 02760 (508) 695-0727
Contact Person: Glenn Leman, Chief Executive Officer
2. DEVICE NAME
Proprietary Name: Acu-Strap Travel and Motion Sickness Band Common/Usual Name: Motion sickness band Classification Information:
Motion sickness bands have not yet been classified by FDA, but have been given the following classification name and product code:
| Name | Product Code | 21 CFR Ref. | Panel |
|---|---|---|---|
| Acupressure device | MVV | To Be Determined | Neurology |
3. PREDICATE DEVICES
Acu-Strap™ Travel and Motion Sickness Band is substantially equivalent to the Sea-Band, 510(k) No. K033268.
4. DEVICE DESCRIPTION
The Acu-Strap™ Travel and Motion Sickness Band product comprises a pair of wristbands, each with a round button added to the interior face of the band. Because the Acu-Strap™ Travel and Motion Sickness Band is stretchable, it will be sold in only one size. The Acu-Strap™ Travel and Motion Sickness Band operates by placing a constant pressure on an acupressure point (the P6 or "Nei-Kuan" point) near the wrist.
1
5. INTENDED USE
The Acu-Strap™ Travel and Motion Sickness Band is intended for the relief of nausca. Nausea may be experienced due to Travel (Motion Sickness), Pregnancy (Morning Sickness), Anesthesia or Chemotherapy.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
Acu-Strap™ Travel and Motion Sickness Band is made of a stretchable fabric material with a hard plastic button that is snapped in place during manufacturing process. It is similar to the predicate device in terms of dimensions, materials, and mechanical characteristics.
7 PERFORMANCE TESTING
Acu-Strap™ Travel and Motion Sickness Band has been subjected to testing for dimensions, elasticity, and relative pressure.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 8 - 2004
Health Enterprises, Inc. C/o Mr. Daniel J. Dillon Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
Re: K041877 Trade/Device Name: Acu-Strap™ Travel and Motion Sickness Band Regulatory Name: Acupressure Device Regulatory Class: Unclassified Product Code: MVV Dated: September 20, 2004 Received: September 22, 2004
Dear Mr. Dillon:
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. Daniel J. Dillon
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 yours.
Mark A. Millmann
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
510(k) Number (if known): K041877
Acu-Strap™ Travel and Motion Sickness Band Device Name:
Indications for Use:
The Acu-Strap™ Travel and Motion Sickness Band is intended for the relief of nausea. Nausea may be experienced due to Travel (Motion Sickness), Pregnancy (Morning Sickness), Anesthesia or Chemotherapy.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark N Milkers
Sion-Division of General, Restorative, and Neurological Devices
510(k) Number K041877