Digital tens one channel

GUDID 04716770005607

BESMED HEALTH BUSINESS CORP.

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID04716770005607
NIH Device Record Keyf523f01d-6a27-4a9f-b711-30960e548785
Commercial Distribution StatusIn Commercial Distribution
Brand NameDigital tens one channel
Version Model NumberBE-560
Company DUNS658023775
Company NameBESMED HEALTH BUSINESS CORP.
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104716770005607 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IPFStimulator, Muscle, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-23
Device Publish Date2016-09-07

On-Brand Devices [Digital tens one channel]

04716770925509BE-92550
04716770005607BE-560

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