FDA.reportPublic FDA data

VIVA 360+ Smart Scale

Primary DI
00073796237509
Brand
VIVA 360+ Smart Scale
Company
Omron Healthcare, Inc.
Model
BCM-750
Device description
VIVA 360+ Smart Scale is intended to be used to calculate and display the estimated value of body fat percentage, subcutaneous fat percentage, skeletal muscle percentage, resting metabolism, body water percentage, bone mass, fat free mass and visceral fat levels using the BI (Bioelectrical Impedance) method and indicates the BMI (Body Mass Index). The VIVA 360+ Smart Scale is intended to be used by healthy individuals in the age range of 18 to 80 years for the subcutaneous fat percentage and visceral fat level. The age range for body fat percentage, skeletal muscle percentage, resting metabolism, body water percentage, bone mass and fat free mass are intended to be used by healthy individuals between the age of 6 to 80 years. The device is intended for multiple-patient, multiple-use
Published
2026-06-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
PUHAnalyzer, Body Composition, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUHAnalyzer, Body Composition, ExemptCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00073796237509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00073796237509000737962375090737962375090073796237509

GMDN Terms#

Term, Definition table
TermDefinition
Bioelectrical body composition analyserAn electronic device designed to estimate body composition (i.e., percent body fat, lean, bone, and/or hydration) with regards to bioelectrical impedance analysis (BIA) and often personal characteristics (e.g., age, gender, height, weight). It may be in the form of a unit with electrodes applied to the surface of the patient’s body, or a scale(s) placed on the floor and upon which the patient stands to measure total body weight. Both types perform BIA by passing a low electrical current through the body; personal characteristics may be manually entered. Data are analysed to provide measurements that may include body mass index (BMI), fat/muscle/bone mass, and total body water percent.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
8006344350ohiquality@omron.com

Regulatory Flags#

DUNS number
054318779
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Primary DI, Brand, Company table
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