SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES

K083838 · Fook Tin Technologies Limited · MNW · May 12, 2009 · Cardiovascular

Device Facts

• Record ID: K083838
• Device Name: SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES
• Applicant: Fook Tin Technologies Limited
• Product Code: MNW · Cardiovascular
• Decision Date: May 12, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Scaleman Body Fat Scales - Models in "Family Model List 1A" is a series of body composition analyzers that measure body weight and impedance and estimate percentage of body fat and body water using BIA (bioelectrical impedance analysis). They are intended for use by healthy children 10-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment. The Scaleman Body Fat Scales - Models in "Family Model List 1B" is a series of body composition analyzers that measure body weight and impedance and estimate percentage of body fat and body water, bone mass and muscle mass using BIA (bioelectrical impedance analysis). They are intended for use by healthy children 10-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment.

Device Story

Scaleman Body Fat Scales are body composition analyzers using foot-to-foot bioelectrical impedance analysis (BIA). Device measures body weight and electrical impedance; estimates body fat, body water, bone mass, and muscle mass. Used in home environment by consumers. User stands on scale; device applies 50 KHz signal; internal electronics calculate composition metrics based on impedance. Output displayed to user for personal health monitoring. Benefits include tracking body composition changes over time.

Clinical Evidence

Comparative clinical study evaluated Scaleman scales against predicate device. Sample size not specified. Primary endpoints included body fat (%), FFM (kg), body water (%), muscle mass (kg), bone mass (kg), and weight (kg). Results showed significant correlation (P<.05) between test and predicate devices in both normal and athlete modes.

Technological Characteristics

Foot-to-foot bioelectrical impedance analysis (BIA) at 50 KHz. 2 or 4 electrode configuration. Powered by replaceable 9V, CR2032, or AAA batteries. Form factor is a digital scale. No specific material standards or software architecture details provided.

Indications for Use

Indicated for healthy children 10-17 years old and healthy adults with active, moderately active, or inactive lifestyles for body composition assessment in home environments.

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.

Predicate Devices

• Tanita Innerscan Body Composition Monitor (K040778)

Submission Summary (Full Text)

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| 510(k) Summary | |
|--------------------------|--|
| Scaleman Body Fat Scales | |

CONFIDENTIAL

| Submitter Name: | Fook Tin Technologies Ltd. | MAY 12 2009 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Submitter Address: | 4/F Eastern Center, 1065 King's Road, Quarry Bay, Hong Kong | |
| Contact Person: | Dr. John Chai, Managing Director | |
| Phone Number: | (852) 2960 7288 | |
| Fax Number: | (852) 2565 9672 | |
| Date: | October 30, 2008 | |
| Device Trade Name: | Scaleman Body Fat Scales | |
| Device Common Name: | Impedance plethysmograph (body composition analyzer/scales) | |
| Classification Name: | Impedance plethysmograph | |
| Classification Number: | 21 CFR 870.2770 | |
| Product code: | MNW | |
| Predicate Device: | Tanita Innerscan Body Composition Monitor, K040778 | |
| Statement of Intended Use: | The Scaleman Body Fat Scales - Models in "Family Model List 1A" is a series of body composition analyzers that measure body weight and impedance and estimate percentage of body fat and body water using BIA (bioelectrical impedance analysis). They are intended for use by healthy children 10-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment. | |

The Scaleman Body Fat Scales - Models in "Family Model List 1B" is a series of body composition analyzers that measure body weight and

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# CONFIDENTIA

impedance and estimate percentage of body fat and body water, bone mass and muscle mass using BIA (bioelectrical impedance analysis). They are intended for use by healthy children 10-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment.

Device Description, Summary of Technologica! Characteristics, and Comparison to the Predicate Device

The models in Scaleman body fat scales' Family Model List 1A and 1B submitted in this 510(k) are body composition analyzers. The devices estimate percentages of body fat, body water, bone mass and muscle mass (as noted in the indications statement) based on bioelectrical impedance analysis (BIA). The following table illustrates the substantial equivalence in technology and intended use to the predicate device.

| Feature | Proposed Device:<br>Scaleman Body Fat Scales<br>(Model FS-148BW1) | Predicate Device:<br>Tanita InnerScan Body Composition<br>Monitor (Model BC-533) |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | NIL | K040778 |
| Manufacturer | Fook Tin Technologies Ltd. | Tanita Corp of America |
| Classification # | 21 CFR 870.2770 | 21 CFR 870.2770 |
| Product code | MNW | MNW |
| Indication for use | The Scaleman Body Fat Scales -<br>Models in "Family Model List 1A" is a<br>series of body composition analyzers<br>that measure body weight and<br>impedance and estimate percentage<br>of body fat and body water using BIA<br>(bioelectrical impedance analysis).<br>They are intended for use by healthy<br>children 10-17 years old and healthy<br>adults with active, moderately active,<br>to inactive lifestyles for body<br>composition assessment in the home<br>environment.<br><br>The Scaleman Body Fat Scales -<br>Models in "Family Model List 1B" is a<br>series of body composition analyzers | The Tanita family of InnerScan Body<br>Composition Monitors measure body<br>weight and impedance and estimate<br>percentage of body fat and body water,<br>visceral fat rating, bone mass, muscle<br>mass, physique rating, daily calorie<br>intake (DCI) and metabolic age using<br>BIA. They are intended for use by<br>healthy children 7-17 years old and<br>healthy adults with active, moderately<br>active, to inactive lifestyles for body<br>composition assessment in the home<br>environment. |

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## UUINFIDEN I IAL

| | that measure body weight and<br>impedance and estimate percentage<br>of body fat and body water, bone<br>mass and muscle mass using BIA<br>(bioelectrical impedance analysis).<br>They are intended for use by healthy<br>children 10-17 years old and healthy<br>adults with active, moderately active,<br>to inactive lifestyles for body<br>composition assessment in the home<br>environment. | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Device description | Body composition analyzer/scale that utilizes a “foot-to-foot” bioelectrical impedance (BIA) technology to determine internal body composition. | Body composition analyzer/scale that utilizes a “foot-to-foot” bioelectrical impedance (BIA) technology to determine internal body composition. |
| Analysis method | BIA | BIA |
| Operating parameters | 50 KHz | 50 KHz |
| Power source | Replaceable 9V or CR2032 or AAA batteries, depending on the model | AA batteries |
| Operating keys | Range of 3 to 6, depending on the model | 13 |
| Number of electrodes | 4 or 2 | 4 |
| Clinical performance | A comparative clinical study, submitted in this notification (Section 20), showed<br>that body fat (%) and FFM (kg) in normal and athlete modes, body water (%)<br>muscle mass (kg), bone mass (kg) and weight (kg) measured or estimated by<br>test and predicate devices were significantly correlated (P<. 05). | |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

MAY 12 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Fook Tin Technologies Ltd c/o Dr. John Chai Managing Director 4/F Eastern Center 1065 King's Road Quarry Bay, Hong Kong

Re: K083838

Trade/Device Name: Scaleman Body Fat Scales Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II (two) Product Codes: MNW Dated: April 18, 2009 Received: May 5, 2009

Dear Dr. Chai:

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. Iisting 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 such 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.

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Page 2 – Dr. John Chai

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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours.

Dima R. Willing

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

### 510(k) Number (if known): KO83838

Device Name: Scaleman

Indications For Use:

Family Model List 1A

A scries of body composition analyzers that measure body weight and impedance and estimate percentage of body fat and body water, using BIA (bioelectrical impedance analysis).

They are intended for use by healthy children 10-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment.

Family Model List 1B

A series of body composition analyzers that measure hody weight and impedance and estimate percentage of body fat and body water, bone mass and muscle mass using BIA (bioelectrical impedance analysis). They are intended for use by healthy children 10-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment.

NO Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Holmes

n of Cardiovascular Devices

510/k) Numbe

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