BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT

K994242 · Bodystat , Ltd. · MNW · Mar 15, 2000 · Cardiovascular

Device Facts

• Record ID: K994242
• Device Name: BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT
• Applicant: Bodystat , Ltd.
• Product Code: MNW · Cardiovascular
• Decision Date: Mar 15, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Intended Use

MEASUREMENT OF: ESTIMATED: Body FAT BODY LEAN+ DRY LEAN TOTAL BODY WATER METABOLIC RATES ACTUAL: BODY MASS INDEX (BMI) WAIST / HIP RATIO IMPEDANCE AT 50 kHZ

Device Story

Bodystat 1500MDD is a body composition monitoring unit. Device measures electrical impedance of the human body at 50 kHz. Input signal is processed to estimate body composition metrics including body fat, lean mass, total body water, and metabolic rates. Device also calculates actual values for BMI and waist/hip ratio. Used in clinical or general settings to assist healthcare providers in assessing patient body composition. Output provides quantitative data to support nutritional or health status monitoring. Benefits include non-invasive assessment of body composition components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bioelectrical impedance analysis (BIA) device operating at 50 kHz. Measures body impedance to derive body composition estimates. Standalone unit.

Indications for Use

Indicated for the measurement and estimation of body composition parameters including body fat, body lean, dry lean, total body water, metabolic rates, BMI, waist/hip ratio, and impedance at 50 kHz in patients.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2000

Mr. I. J. Meeuwsen Managing Director Bodystat® Limited P. O. Box 50 Douglas Isle of Man IM99 1DQ BRITISH ISLES

Re: K994242

Bodystat® 1500MDD Body Composition Monitoring Unit Dated: December 6, 1999 Received: December 16, 1999 Requiatory Class: II 21 CFR §870.2770/Procode: 74 MNW

Dear Mr. Meeuwsen:

We have reviewed your Section 510(k) notification of intent to market the device and we 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 Cosmelic Act (Act). 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 recisitation, listing of devices, good manufacturing and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), 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 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/odrh/dsmaldsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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510(k) Number (if known): BODYSTAT (1.500 M. Device Name:_________

Indications For Use:

MEASUREMENT OF:
ESTIMATED: Body FAT
BODY LEAN+
DRY LEAN
TOTAL BODY WATER
METABOLIC RATES

ACTUAL: BODY MASS INDEX (BMI)
WAIST / HIP RATIO
IMPEDANCE AT 50 kHZ

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use***_***_
(Per 21 CFR 801.109)

(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices ળીવ 510(k) Number

Over-The-Counter Use V

(Optional Format 1-2-96)