SONAMET BODY COMPOSITION ANALYZER

K924972 · Life Measurement Instruments, Inc. · OAC · Feb 13, 1995 · Cardiovascular

Device Facts

• Record ID: K924972
• Device Name: SONAMET BODY COMPOSITION ANALYZER
• Applicant: Life Measurement Instruments, Inc.
• Product Code: OAC · Cardiovascular
• Decision Date: Feb 13, 1995
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Device Story

SONAMET Body Composition Analyzer utilizes air displacement plethysmography to measure body composition. Device operates by measuring volume of air displaced by subject within chamber; principle based on Boyle's Law. Used in clinical settings to assess body fat and lean mass. Output provides quantitative body composition data to healthcare providers for nutritional or health status evaluation.

Technological Characteristics

Air displacement plethysmograph; utilizes air volume displacement measurement principle; Class II device; product code OAC.

Regulatory Classification

Identification

An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.

Special Controls

*Classification.* Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

APR 13 2007

Food and Drug Administration

9200 Corporate Boulevard

Rockville MD 20850

Mr. Alex Urlando

Vice President, Operations

Life Measurement, Inc.

1850 Bates Avenue

CONCORD CA 94520

Re: K924972

Trade/Device Name: SONAMET Body Composition Analyzer

Regulation Number: 21 CFR§870.2770

Regulation Name: Air Displacement Plethysmograph for Body Composition Analysis

Regulatory Class: Class II

Product Code: OAC

Dated: November 18, 1993

Received: November 22, 1993

Dear Mr. Urlando:

This letter corrects our substantially equivalent letter of February 13, 1995.

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 (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 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

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Page 2 – Mr. Alex Urlando

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.

This letter will allow you to continue 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,

Nancy C. Brogdon

Nancy C. Brogdon

Director, Division of Reproductive,

Abdominal and Radiological Devices

Office of Device Evaluation

Center for Devices and

Radiological Health