Precision TENS3900 TENS3900V2-MFR

GUDID 10850209007013

PRECISION TENS3900 4 MODE 90mA ANALOG TENS UNIT WITH TIMER

MEDICAL FINANCE RESOURCES INC

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID10850209007013
NIH Device Record Keyc15c6727-c3b0-42ad-9512-adeef849c6b4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrecision TENS3900
Version Model NumberTENS3900V2-MFR
Catalog NumberTENS3900V2-MFR
Company DUNS938569712
Company NameMEDICAL FINANCE RESOURCES INC
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850209007016 [Primary]
GS100850209007023 [Package]
Contains: 00850209007016
Package: KIT [1 Units]
In Commercial Distribution
GS110850209007013 [Package]
Contains: 00850209007023
Package: CASE [32 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-29
Device Publish Date2019-11-21

Devices Manufactured by MEDICAL FINANCE RESOURCES INC

30850209007000 - TENSTRODE2019-11-29 2" X 2" SQUARE TAN CLOTH ELECTRODE POLY BAG 4/PK
10850209007013 - Precision TENS39002019-11-29PRECISION TENS3900 4 MODE 90mA ANALOG TENS UNIT WITH TIMER
10850209007013 - Precision TENS39002019-11-29 PRECISION TENS3900 4 MODE 90mA ANALOG TENS UNIT WITH TIMER
10850209007075 - ComfyComboPlus2019-11-29 DIGITAL TENS/MUSCLE WITH 7 MODES AND 24 PRESETS

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