ACU-STRAP MOTION SICKNESS BAND

K041877 · Health Ent., Inc. · MVV · Oct 8, 2004 · NE

Device Facts

• Record ID: K041877
• Device Name: ACU-STRAP MOTION SICKNESS BAND
• Applicant: Health Ent., Inc.
• Product Code: MVV · NE
• Decision Date: Oct 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for 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.

Device Story

Acu-Strap™ is a pair of stretchable fabric wristbands featuring an integrated hard plastic button. Device operates via mechanical acupressure; user places band on wrist so button applies constant pressure to P6 (Nei-Kuan) acupressure point. Intended for patient self-use to alleviate nausea associated with travel, pregnancy, anesthesia, or chemotherapy. No external power, software, or complex processing required.

Clinical Evidence

Bench testing only. Testing performed to verify dimensions, elasticity, and relative pressure characteristics.

Technological Characteristics

Stretchable fabric wristband with integrated hard plastic button. Mechanical acupressure sensing/actuation principle. No energy source. Dimensions and materials are similar to predicate. Non-sterile.

Indications for Use

Indicated for relief of nausea in patients experiencing motion sickness, morning sickness, or nausea secondary to anesthesia or chemotherapy. Available for over-the-counter use.

Predicate Devices

• Sea-Band (K033268)

Submission Summary (Full Text)

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### 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 [phone]

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.

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#### 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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 [phone]. 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 [phone] or [phone] 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