BARF BAND

K110821 · Doodlebug Products, LLC · MVV · Feb 27, 2012 · NE

Device Facts

• Record ID: K110821
• Device Name: BARF BAND
• Applicant: Doodlebug Products, LLC
• Product Code: MVV · NE
• Decision Date: Feb 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for Use

The Barf Band is indicated for the relief of nausea. Nausea is a symptom that may be experienced due to a variety of causes, for example: pregnancy (morning sickness), motion sickness, anesthesia and chemotherapy.

Device Story

Barf Band is an acupressure wristband designed for nausea relief. Device features adjustable polyurethane band with integrated plastic dome/stud (ABS plastic covered with Santoprene) and cotton lining. Operates by applying mechanical pressure to Nei Kuan (P6) acupressure point on each wrist. Intended for over-the-counter use by patients to alleviate nausea associated with pregnancy, motion sickness, anesthesia, or chemotherapy. No electronic components, software, or external power sources involved. Clinical benefit derived from non-invasive acupressure stimulation.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing confirmed that the force applied by the wristband is within the range established by predicate devices.

Technological Characteristics

Wristband constructed of PVC-free polyurethane, ABS plastic, Santoprene, and cotton. Operates via mechanical pressure on P6 acupressure point using a plastic dome/stud. Non-powered, manual adjustment.

Indications for Use

Indicated for relief of nausea in patients experiencing symptoms due to pregnancy (morning sickness), motion sickness, anesthesia, or chemotherapy.

Predicate Devices

• PSI Band by Psi Health Solutions, Inc. (K070766)
• Sea Band by Sea-Band Limited (K033268)

Submission Summary (Full Text)

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K110821

# FEB 2 7 2012

#### 510(k) SUMMARY

Doodlebug Products's Barf Band

Date Prepared:

1/30/2012

#### Name of Device and Name/Address of Sponsor

Doodlebug Barf Band

Doodlebug Products 1809 Rockmoor Ave Austin, Tx 78703 Phone: [phone]

Common or Usual Name:

Barf Band

Classification Name:

Acupressure Device

Predicate Devices

PSI Band by Psi Health Solutions, Inc.

Sea Band by Sea-Band Limited

### Intended Use / Indications for Use

The Barf Band is indicated for use in: The Barf Band is indicated for the relief of nausea. Nausea is a symptom that may be experienced due to a variety of causes, for example: pregnancy (morning sickness), motion sickness, anesthesia and chemotherapy.

### Technological Characteristics

The Barf Band is a wristband with adjustable properties that operates by putting pressure on Nei Kuan acupressure point (also known as the P6 point) on each wrist by means of a plastic dome/stud. The P6

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Barf Bands are made from PVC free polyurethane, ABS plastic covered with Santoprene and 100% cotton. The band itself is composed of polyurethane. The ABS plastic covered with Santoprene is used to construct the plastic dome/stud that applies the pressure to the P6 point. The cotton is used inside the band to make the band comfortable to the end user.

#### Substantial Equivalence

The Barf Band is as safe and effective as the PSI Band (K070766) and Sea Band (K033268). The Barf Band has the same intended uses and indications for use, similar technological characteristics, and same principles of operation as its predicate device. The minor technological differences between the Barf Band and its predicate devices (e.g., dimensional and material composition) raise no new issues of safety or effectiveness. Performance testing conducted on the Barf Band and the predicate devices supports this. The force applied by the Barf Band wristband falls within the range established by the predicate devices. Thus, the Barf Band is substantially equivalent.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its wings, positioned to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Doodlebug Products, LLC c/o Barry E. Sands ROMIS Inc., President 5 Hemingway Lane, West Newbury, MA 01985

Re: K110821

Trade/Device Name: Barf Band Regulation Number: none Regulation Name: n/a Regulatory Class: unclassified Product Code: MVV Dated: January 30, 2012 Received: January 31, 2012

Dear Mr. Sands:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 or any I with all the Act s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FEB 2 7 2012

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## Page 2 - Mr. Barry E. Sands

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

for

Sincerely yours,

Keira Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

### Enclosure

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### Indications for Use Statement

510(k) Number (if known): NA

K110821

Device Name: Barf Band

Indications for Use:

The Barf Band is indicated for the relief of nausea. Nausea is a symptom that may be experienced due to a variety of causes, for example: pregnancy (morning sickness), motion sickness, anesthesia and chemotherapy.

Prescription Use (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use_X (21 C.F.R. 807 Subpart C)

(Please DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tesin.

K110821

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

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510(k) Number.