DIGITAL TENS ONE CHANNEL

GUDID 04716770925608

DIGITAL TENS ONE CHANNEL

BESMED HEALTH BUSINESS CORP.

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID04716770925608
NIH Device Record Key95875c2c-595c-4e19-b976-853d3de131ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIGITAL TENS ONE CHANNEL
Version Model NumberBE-92560
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 Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104716770925608 [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 Date2017-12-15

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