ROWENTA INC. BODYPARTNER VISION, MODEL BM 210 (2079565620)

K023429 · Rowenta, Inc. · MNW · Sep 23, 2003 · Cardiovascular

Device Facts

• Record ID: K023429
• Device Name: ROWENTA INC. BODYPARTNER VISION, MODEL BM 210 (2079565620)
• Applicant: Rowenta, Inc.
• Product Code: MNW · Cardiovascular
• Decision Date: Sep 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Indications for Use

The Rowenta Bodypartner VISION/SCALE is intended to measure weight and body impedance which are used to calculate an estimated value for fat mass and lean mass.

Device Story

The Rowenta Bodypartner VISION (Model BM 210) is an impedance plethysmograph designed for home use. It measures body weight and electrical impedance; these inputs are processed to calculate estimated fat mass and lean mass. The device provides these measurements to the user for personal health monitoring. It functions as a scale, requiring the user to stand on the device to complete the circuit for impedance measurement.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Impedance plethysmograph (21 CFR 870.2770). Measures body weight and electrical impedance to derive body composition estimates. Class II device.

Indications for Use

Indicated for individuals seeking to measure body weight and estimate body composition, specifically fat mass and lean mass, via impedance plethysmography.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 2003

Mr. Mike Cosco Product Manager Rowenta Inc. 196 Boston Avenue MEDFORD MA 02155

Re: K023429

Trade/Device Name: BODYPARTNER VISION Model BM 210 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: June 23, 2003 Received: June 25, 2003

Dear Mr. Cosco:

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. Ilsting 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 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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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 one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

l'age 2

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## INDICATIONS FOR USE

## 510 (k) Number: K023429

| Device name: | ROWENTA BODYPARTNER VISION Model BM-210 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use: | The Rowenta Bodypartner VISION/SCALE is intended to measure weight<br>and body impedance which are used to calculate an estimated value for fat<br>mass and lean mass. |
| Company name: | Rowenta Inc. 196 Boston Avenue, Medford, MA 02155 USA |

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Concurrent of CDRH, Office of Device Evaluation (ODE)

David A. Seymore

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

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-the-Counter Use