Profile by Sanford

Basic Information

• Brand Name: Profile by Sanford
• Primary DI: 00811392021029
• Version / Model: LS206-E
• Company Name: PROFILE PRODUCTS, LLC
• Labeler DUNS: 080392779
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-31
• Public Version: 4
• Public Version Date: 2023-08-31
• Public Version Status: Update
• Public Device Record Key: 6953e457-8d21-455c-bef0-0b13c910dadc

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MNW	Analyzer, Body Composition	Cardiovascular	870.2770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38211	Stand-on floor scale, electronic	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10811392021026	GS1	Case	4	Not in Commercial Distribution	2023-08-31
Primary	00811392021029	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K123781	000

Device Sizes

Type	Value	Unit	Text
Width	12.5	Inch
Length	12.5	Inch
Height	1	Inch

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: – 90 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 90 – Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 86 – 106 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius