SEA-BAND

K033268 · Sea-Band UK , Ltd. · MVV · Jan 7, 2004 · NE

Device Facts

• Record ID: K033268
• Device Name: SEA-BAND
• Applicant: Sea-Band UK , Ltd.
• Product Code: MVV · NE
• Decision Date: Jan 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for Use

The Sea-Band Limited "Sea-Band" is indicated for the relief of nausea. (Nausea is a symptom that may be experienced due to a variety of causes, for example: - . Travel/Motion - Pregnancy (Morning Sickness) . - Chemotherapy . - Post Operative) .

Device Story

Sea-Band consists of elasticated wrist band with integrated plastic button; worn in pairs on wrists. Button applies mechanical pressure to P6 (nei-kuan) acupuncture point. Used by patients for relief of nausea associated with travel, pregnancy, chemotherapy, or post-operative recovery. Non-invasive, drug-free, over-the-counter device. Mechanism relies on acupressure stimulation to alleviate nausea symptoms.

Clinical Evidence

Published clinical evaluations, biocompatibility data, and bench testing of physical properties demonstrate safety and effectiveness. No specific clinical trial metrics provided in summary.

Technological Characteristics

Elasticated wrist band with plastic button for acupressure. Non-powered, mechanical stimulation. No software or electronic components.

Indications for Use

Indicated for relief of nausea in patients experiencing symptoms due to travel/motion, pregnancy (morning sickness), chemotherapy, or post-operative recovery.

Predicate Devices

• Acu-Band (K900588)
• ReliefBand Device Models RB-DL, RB-EL and RB-RL (K020180)
• ReliefBand Device Models WB-2L, WB-6L, and WB-RL(Rx) (K994387)
• ReliefBand NST Device Models WB-2L (K983907)
• ReliefBand Device Models RB-2, RB-6 and RB-R (OTC) (K982967)
• ReliefBand Device Models WB-2, WB-6, WB-R (K982436)
• ReliefBand Device Model SW-111 (K980333)

Reference Devices

• Travel Smart by Victor Kiam NoQweez Motion Discomfort Wrist Bands
• TRAVEL BAND (Danelco Industries Ltd.)
• VALET TRAVELAIDE WRISTBANDS (Mayday Inc.)
• FIRST AID EZY TRAVELER WRISTBAND (Apothecary Products Inc.)
• Davis QUEAZ-AWAY Travelers' Wristbands (David Instruments)
• Accu-Presure BANDS (Standard Merchandising Co.)
• RISSBAND (Rissband Inc.)
• TRAVELGARDE Acupressure Wrist Band (Marine Logic Inc.)
• BioBands (K822306)
• MedicMates Anti Sickness Bands
• THE TRAVELEZE

Submission Summary (Full Text)

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## 510(k) SUMMARY

# SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE SEA-BAND LTD SEA-BAND

#### SUBMITTER INFORMATION

| Submitter Company Name | Sea-Band Ltd |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Company Address | Sea-Band Ltd<br>Lancaster Road<br>Hinckley<br>Leicestershire LE10 0AW<br>England |
| Submitter Telephone | 011 44 1455 639750 |
| Submitter Facsimile | 011 44 1455 639751 |
| Submitter Contact Person | Neil R. Armstrong<br>Regulatory Affairs Advisor to Sea-Band Ltd<br>MeddiQuest Limited<br>Business & Technology Center<br>Bessemer Drive<br>Stevenage SG1 2DX<br>England<br>Telephone: [phone]<br>Fax: [phone] |
| Date Summary Prepared | August 15, 2003 |

#### DEVICE IDENTIFICATION

Trade/Proprietary Name Classification Name

Sea-Band To be determined:

Mr. Ted Stevens, D.G.R.N.D. Branch Chief at O.D.E. was contacted requesting a classification determination on April 09,2002. This facsimile was treated as a 513(q) request for classification determination and passed to Mr. Steve Hinckley.

Since this time we have corresponded with Mr. Hinckley by e-mail, fax and telephone and in our latest telephone conversation (on 03/10/2003) Mr. Hinckley requested that we submit our 510(k) without Product Code, Regulation Number or Classification name.

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#### DEVICE DESCRIPTION

The "Sea-Band" consists of elasticated wrist band with a plastic button. The button is designed to apply pressure to the P6 or "nei-kuan", acupuncture point.

"Sea-Bands" are designed to be worn on each wrist and are supplied in pairs in a plastic case. The case is contained in an outer cardboard box with instructions for use.

The Sea-Band Ltd , Sea-Band will be available in a variety of different colors and pack types.

#### INDICATIONS FOR USE

The Sea-Band Ltd "Sea-Band" is indicated for the relief of nausea.

(Nausea is a symptom that may be experienced due to a variety of causes, for example:

- . Travel/Motion
- . Pregnancy (Morning Sickness)
- Chemotherapy .
- Post Operative) .

## TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the Sea-Band Ltd "Sea-Band" and the predicate devices has been performed.

The only significant difference in technological characteristic is between the Sea-Band Ltd "Sea-Band" and the Woodside Biomedical, Inc. "Relief Bands®". The "Relief Bands®" products use electrical rather than pressure stimulation, however FDA has already determined substantial equivalence of these two methods of nerve stimulation (PreMarket Notification submissions made by Maven Laboratories Inc. for the original Relief Bands).

#### PERFORMANCE DATA

Published clinical evaluations, biocompatibility data and bench testing of physical properties of realtime age data demonstrate that the Sea-Band Ltd "Sea-Band" is safe and effective for its intended use and substantially equivalent to the predicate products.

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| Common/Usual Name<br>Classification | See Classification Name above<br>Class II |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Ms. Gladys Rodriguez, Acting Director of<br>Division of Enforcement III at the CDRH Office<br>Compliance requested a 510(k) submission in<br>her letter to Mr. Byron Chatburn, Managing<br>Director of Sea-Band Ltd , of February 06<br>2002. |
| Product Code | See Classification Name above |

# IDENTIFICATION OF PREDICATE DEVICE

Substantial Equivalence to Acu-Band K900588

The Sea-Band manufactured by Sea-Band Ltd is substantially equivalent to the Acu-Band by Euro Am Pharma Inc.

Substantial Equivalence to various ReliefBand® Products

The Sea-Band Ltd "Sea-Band" is also substantially equivalent to various "Relief Band" products manufactured by Woodside Biomedical, Inc.

| K Number | Product |
|----------|----------------------------------------------------------|
| K020180 | ReliefBand® Device Models<br>RB-DL, RB-EL and RB-RL |
| K994387 | ReliefBand® Device Models WB-2L,<br>WB-6L, and WB-RL(Rx) |
| K983907 | ReliefBand® NSTTM Device Models<br>WB-2L |
| K982967 | ReliefBand® Device Models RB-2, RB-<br>6 and RB-R (OTC) |
| K982436 | ReliefBand® Device Models WB-2,<br>WB-6, WB-R |
| K980333 | ReliefBand® Device Model SW-111 |

Substantial Equivalence to Other Products

Other similar products to the Sea-Band Ltd Sea-Band that are believed to have been marketed in the USA, and to which the Sea-Band may be substantially equivalent include:

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Travel Smart by Victor Kiam -NoQweez Motion Discomfort Wrist Bands - also makes claims for Motion sickness.

Franzus Company Inc. 10 Railroad Ave. Beacon Falls, CT06403 NoQweez is a Cirrus Air Technologies Trademark Model WVK-186NQ Made in USA Marketed by Wal Mart - box dated 1998 Made in USA

TRAVEL BAND - Claims for Travel and M/Sickness Danelco Industries Ltd. 4 - 12880 Bayhgate Way Richmond, BC Canada V6V 1Z4

VALET - TRAVELAIDE WRISTBANDS -Motion Sickness Mayday Inc. 1121 Chesnut Street Burbank CA 91506 Tel.[phone] Made in USA

FIRST AID -- EZY TRAVELER WRISTBAND -- Motion Sickness Apothecary Products Inc. Minneapolis MN 55337 Made in USA

Davis – QUEAZ-AWAY Travelers' Wristbands David Instruments 3465 Diablo Ave. Haywood CA 945 45 Made in USA

Accu-Presure BANDS - for travel Standard Merchandising Co. Camden NJ 08103 Made in USA

RISSBAND - Motion Sickness and Pregnancy Rissband Inc. 100 Spark Street Brockton MA 02402 Made in USA Copyright on leaflet 1989

TRAVELGARDE Acupressure Wrist Band Marine Logic Inc. 400 Australian Ave. Suite 725 West Palm Beach FL. 33401 Tel [phone] Made in USA

BioBands - Morning Sickness - K822306 BioBands Inc. NY 10010 Patent 5078728 Made in USA

MedicMates – Anti Sickness Bands for sea travel and morning sickness MedicMates Ltd GU1 2DT (UK) Made in USA

Acuband - Travel Sickness nausea - K900588 AcuBand Ltd Suite 1B Market Centre Western International Market Hayes Rd. Southall Middlesex UK

THE TRAVELEZE -- Travel Sickness The Traveleze PO Box 30 Blundell Lane Bursledon Nr. Southampton UK

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized emblem featuring three horizontal lines that curve upwards, resembling a bird in flight or a stylized representation of human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 7 2004

Sea- Band UK Ltd. C/o Mr. Neil R. Armstrong MeddiQuest Limited Business & Technology Center, Bessemer Drive Stevenage, Herts. United Kingdom SG1 2DX

Re: K033268

Trade/Device Name: Sea-Band Limited - "SeaBand" Regulation Name: Accu pressure device Regulatory Class: Unclassified Product Code: MVV Dated: September 1, 2003 Received: October 9, 2003

Dear Mr. Armstrong:

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 I'DA'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. Neil R. Armstrong

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 responsibilitics 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 N Wilkerson

Celia M. Witten, PhD, MD 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): K033268

Sea-Band Limited - "SeaBand" Device Name:

Indications For Use:

The Sea-Band Limited "Sea-Band" is indicated for the relief of nausea.

(Nausea is a symptom that may be experienced due to a variety of causes, for example:

- . Travel/Motion
- Pregnancy (Morning Sickness) .
- . Chemotherapy
- Post Operative) .

for Mark N Milkens

General Restorative Deleal Devices

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ V (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)

(Posted November 13, 2003)

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