(347 days)
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.
Not Found
This document is a 510(k) premarket notification letter from the FDA for a device called the "BODYPARTNER VISION Model BM 210." It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter confirms that the FDA has reviewed the 510(k) submission and determined the device is substantially equivalent to legally marketed predicate devices. It outlines general controls and regulations applicable to the device. The indications for use are also described, stating the device "is intended to measure weight and body impedance which are used to calculate an estimated value for fat mass and lean mass."
Therefore, I cannot provide the requested information from this document. It does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information on a standalone algorithm performance study.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them, resembling a symbol or emblem.
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 weightand body impedance which are used to calculate an estimated value for fatmass and lean mass. |
| Company name: | Rowenta Inc. 196 Boston Avenue, Medford, MA 02155 USA |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
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
§ 870.2770 Impedance plethysmograph.
(a)
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.(b)
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.