BIOBANDS

K051397 · Biobands Distributors, Inc. · MVV · Sep 16, 2005 · NE

Device Facts

• Record ID: K051397
• Device Name: BIOBANDS
• Applicant: Biobands Distributors, Inc.
• Product Code: MVV · NE
• Decision Date: Sep 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for Use

BioBands is indicated for the relief of nausea may be experienced due to a variety of causes, including Travel (Motion Sickness), Pregnancy (Morning Sickness), Anesthesia (Post-Operative) or Chemotherapy.

Device Story

BioBands is an adjustable wristband made of nylon and polyester fabric with a Velcro closure. A wooden bead is sewn into the underside of the band. The device is worn by the user on either wrist to apply continuous mechanical pressure to the P6 (nei-kuan) acupuncture point. This pressure is intended to interrupt signals that trigger nausea. The device is a non-invasive, mechanical aid for symptom relief.

Technological Characteristics

Adjustable wristband constructed from nylon and polyester fabric with Velcro closure and an integrated wooden bead for pressure application. Mechanical operation; no energy source or software.

Indications for Use

Indicated for relief of nausea in patients experiencing motion sickness, morning sickness, post-operative nausea, or chemotherapy-induced nausea.

Predicate Devices

• Sea-Band wristband (K033268)
• Acu-Strap Motion Sickness Band (K041877)

Submission Summary (Full Text)

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# SEP 1 6 2005 510(k) Summary

#### Applicant/Address

- BioBands Distributors, Inc., 30 Waterside Plaza, Suite 36K, New York, NY 10010 0
### Contact Person/Telephone

- Georgia C. Ravitz, Counsel to BioBands Distributors, Inc., (PH) 202-857-8939; (FAX) ០ 202-857-6395.
#### Preparation Date

- 0 May 18, 2005
- Device Trade Name
- ロ BioBands

#### Classification Name

- Acu-pressure Device 0
### Legally Marketed Predicate Devices

- K033268, "Sea-Band" wristband, by Sea-Band UK, Ltd; and K041877, Acu-Strap ០ Motion Sickness Band, by Health Enterprises, Inc.
#### Device Description

- BioBands is an adjustable wristband that fits on either wrist. The device is composed ם from nylon and polyester fabric, and features a Velcro closure for easy adjustment. The BioBands wristband has a wooden bead or button sewn into the band's underside. When BioBands is worn by users, the wooden bead applies pressure to the P6 or "nei-kuan" acupuncture point. The gentle pressure applied by the bead to the P6 interrupts the signals that trigger nausea.
### Intended Use

- BioBands is indicated for the relief of nausea may be experienced due to a ០ variety of causes, including Travel (Motion Sickness), Pregnancy (Morning Sickness), Anesthesia (Post-Operative) or Chemotherapy.

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## Substantial Equivalence Summary

- a BioBands is substantially equivalent to K033268, "Sea-Band" wristband, by Sea-Band BioBands is also substantially equivalent to K041877, Acu-Strap Motion UK, Ltd. Sickness Band, by Health Enterprises, Inc. Both of these devices are similarly constructed wristbands, that utilize the same principal of operation, and that are marketed for the same indications for use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is rendered in black and white.

SEP 1 6 2005

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BioBands Distributors, Inc. c/o Mr. James H. Hartten Regulatory Affairs Analyst Arent Fox PLLC 1050 Connecticut Avenue, NW Washington, DC 20036-5339

Re: K051397

Trade/Device Name: BioBands Regulatory Class: Unclassified Product Code: MVV Dated: August 5, 2005 Received: August 5, 2005

Dear Mr. Hartten:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 1970, as can one with the provisions of the Federal Food, Drug, de nece mat have act (Act) that do not require approval of a premarket approval application (PMA). and Cosmeter For ( 100 ) was the device, subject to the general controls provisions of the Act. The r ou may, mercrore, mains of the Act include requirements for annual registration, listing of general obtarely profice, 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 If your device is onastired (tional controls. Existing major regulations affecting your device can may be our 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 or any I subtar 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 El R Far 8073, accems (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. James H. Hartten

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegin manteing of substantial equivalence of your device to a legally premarket notification: "The Pine of 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 If you desire specific advice for your as novel on one of the regulation entitled, Comation of Complianse w (2 + n notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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. Melkerson
Acting 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

KOS1397 510(k) Number (if known):

BioBands Device Name:

Indications for Use:

BioBands is indicated for the relief of nausea. Nausea may be experienced due to a variety of causes, including Travel (Motion Sickness), Pregnancy (Morning Sickness), Anesthesia (Post-Operative) or Chemotherapy.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Z

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_KOS) 397

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