(140 days)
Not Found
No
The summary describes a device using Bioelectrical Impedance Analysis (BIA) and does not mention AI, ML, or related concepts.
No
The device is used for body composition assessment in healthy individuals and does not claim to treat, diagnose, cure, or prevent any disease or condition.
No
The device is described as a "body composition analyzer" intended for "body composition assessment." While it provides measurements, it doesn't state that it diagnoses any medical conditions.
No
The device description explicitly states it is a "Body composition analyzer/scale" that utilizes "foot-to-foot" bioelectrical impedance technology, indicating it is a physical hardware device, not software only.
Based on the provided information, the Scaleman Body Fat Scales are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Scaleman Device Function: The Scaleman Body Fat Scales measure body weight and impedance using BIA. This is a non-invasive method applied to the body (in vivo) to estimate body composition. It does not involve analyzing specimens taken from the body.
- Intended Use: The intended use is for body composition assessment in the home environment, which aligns with a general wellness or body monitoring device, not a diagnostic test performed on biological samples.
Therefore, the Scaleman Body Fat Scales fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for 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.
Product codes
MNW
Device Description
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).
Body composition analyzer/scale that utilizes a “foot-to-foot” bioelectrical impedance (BIA) technology to determine internal body composition.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
healthy children 10-17 years old and healthy adults
Intended User / Care Setting
Home environment
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A comparative clinical study, submitted in this notification (Section 20), showed that body fat (%) and FFM (kg) in normal and athlete modes, body water (%) muscle mass (kg), bone mass (kg) and weight (kg) measured or estimated by test and predicate devices were significantly correlated (P
§ 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.
0
| 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
1
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:
Scaleman Body Fat Scales
(Model FS-148BW1) | Predicate Device:
Tanita InnerScan Body Composition
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 -
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 | The Tanita family of InnerScan Body
Composition Monitors measure body
weight and impedance and estimate
percentage of body fat and body water,
visceral fat rating, bone mass, muscle
mass, physique rating, daily calorie
intake (DCI) and metabolic age using
BIA. They are intended for use by
healthy children 7-17 years old and
healthy adults with active, moderately
active, to inactive lifestyles for body
composition assessment in the home
environment. |
2
UUINFIDEN I IAL
| | 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 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
that body fat (%) and FFM (kg) in normal and athlete modes, body water (%)
muscle mass (kg), bone mass (kg) and weight (kg) measured or estimated by
test and predicate devices were significantly correlated (P