FDA.reportPublic FDA data

Profile by Sanford

Primary DI
10811392021026
Brand
Profile by Sanford
Company
PROFILE PRODUCTS, LLC
Model
LS206-E
Device description
The Profile Smart Body Scale measures weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle mass in generally healthy adults 18 years of age or older. It is intended for use in the home/domestic setting only.
Published
2017-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNWAnalyzer, Body Composition

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNWAnalyzer, Body CompositionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123781000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123781000TRANSTEK GLASS BODY FAT ANALYZERZhongshan Transtek Electronics Co., Ltd.2013-01-09MNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811392021026PackageGS14In Commercial Distribution
00811392021029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081139202102610811392021026
00811392021029008113920210298113920210290811392021029

GMDN Terms#

Term, Definition table
TermDefinition
Stand-on floor scale, electronicAn electrically-powered device designed to be placed on/integrated into the floor and upon which a patient is intended to stand to measure and display total body weight. It is not designed to weigh a wheelchair-bound patient or bed/stretcher.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height1Inch
Length12.5Inch
Width12.5Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure86 KiloPascal106 KiloPascal
Handling Environment Humidity90 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
605-679-4266corey.condon@sanfordhealth.org

Regulatory Flags#

DUNS number
080392779
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811392021029Profile by SanfordLS206-E2017-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04904785230491Body Composition AnalyzerTANITA CORPORATIONMNW2025-10-24
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08809209592277InBodyInBody Co., Ltd.MNW2025-10-03
00077784049198TAYLORTAYLOR PRECISION PRODUCTS, INC.MNW2025-05-06
20077784049192TAYLORTAYLOR PRECISION PRODUCTS, INC.MNW2025-05-06
08809209590969InBodyInBody Co., Ltd.MNW2024-07-23
00074108499714ConairCONAIR CORPORATIONMNW2024-05-13
B322F0011ES-BC LD TECHNOLOGY, LLCMNW2024-03-05
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08809209590976InBodyInBody Co., Ltd.MNW2023-06-22
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