BODY ANALYSIS SCALE

K112951 · Shenzhen Healthcare Electronic Technology Co., Ltd. · MNW · Nov 1, 2011 · Cardiovascular

Device Facts

• Record ID: K112951
• Device Name: BODY ANALYSIS SCALE
• Applicant: Shenzhen Healthcare Electronic Technology Co., Ltd.
• Product Code: MNW · Cardiovascular
• Decision Date: Nov 1, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Intended Use

The Body analysis scale, Model BF 66 is indicated to measure body weight, estimate body fat, body water percentage, body muscle mass, bones mass, visceral fat rating and daily calorie intake (DCI) using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults who are not ill, feverish, have a chronic or acute disease, or a condition that affects the level of hydration such as pregnancy.

Device Story

Body analysis scale (Model BF 66) uses bioelectrical impedance analysis (BIA) to estimate body composition. Device measures body weight and electrical impedance; processes data to calculate body fat, water percentage, muscle mass, bone mass, visceral fat, and daily calorie intake. Intended for over-the-counter use by healthy adults in home settings. User stands on scale; device provides digital output of metrics. Output assists users in monitoring body composition and health trends. No clinical intervention required; device provides information for personal health management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Impedance plethysmograph (21 CFR 870.2770). Uses BIA (bioelectrical impedance analysis) to measure body composition. Standalone digital scale form factor. Battery-powered.

Indications for Use

Indicated for generally healthy adults to measure body weight and estimate body composition (fat, water, muscle, bone, visceral fat) and daily calorie intake. Contraindicated for individuals who are ill, feverish, have chronic/acute disease, or conditions affecting hydration (e.g., pregnancy).

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 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Shenzhen Healthcare Electronic Technology Co., Ltd. % Mr. Charlie Mack Principal Engineer IRC 77325 Joyce Way ECHO OR 97826

NOV - 1 2011

Re: K112951

Trade/Device Name: Body analysis scale, Model BF 66 Regulation Number: 21 CFR§ 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: October 1, 2011 Received: October 4, 2011

Dear Mr. Mack:

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 comply 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 of medical device-related

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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.

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/CDRH0ffices/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.

Sincerely yours,

Hubert Lemmering

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use 112951 510(k) Number (if known):

Device Name: Body analysis scale, Model BF 66

Indications For Use:

The Body analysis scale, Model BF 66 is indicated to measure body weight, estimate body fat, body water percentage, body muscle mass, bones mass, visceral fat rating and daily calorie intake (DCI) using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults who are not ill, feverish, have a chronic or acute disease, or a condition that affects the level of hydration such as pregnancy.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use イ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulda Gunn

ision Sianductive, Gastro-Renal, and