BEAR 2 Body

GUDID 07350120791856

Bear 2 body is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.

Foreo AB

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID07350120791856
NIH Device Record Keya007850b-924c-486e-904e-651df860cc60
Commercial Distribution StatusIn Commercial Distribution
Brand NameBEAR 2 Body
Version Model NumberLavender
Company DUNS352394143
Company NameForeo AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS107350120791856 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-24
Device Publish Date2024-05-16

On-Brand Devices [BEAR 2 Body]

07350120791863Bear 2 body is intended for body skin stimulation and is indicated for over-the-counter cosmetic
07350120791856Bear 2 body is intended for body skin stimulation and is indicated for over-the-counter cosmetic

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