ComfyComboPlus COMFYCOMBOPLUS-EVMFR

GUDID 10850209007075

DIGITAL TENS/MUSCLE WITH 7 MODES AND 24 PRESETS

MEDICAL FINANCE RESOURCES INC

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID10850209007075
NIH Device Record Key9817460b-0cfd-423b-91cc-b411cc1275ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameComfyComboPlus
Version Model NumberCOMFYCOMBOPLUS-EVMFR
Catalog NumberCOMFYCOMBOPLUS-EVMFR
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
GS100850209007061 [Primary]
GS100850209007078 [Package]
Contains: 00850209007061
Package: KIT [1 Units]
In Commercial Distribution
GS110850209007075 [Package]
Contains: 00850209007078
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 TENS39002019-11-29 PRECISION TENS3900 4 MODE 90mA ANALOG TENS UNIT WITH TIMER
10850209007075 - ComfyComboPlus2019-11-29DIGITAL TENS/MUSCLE WITH 7 MODES AND 24 PRESETS
10850209007075 - ComfyComboPlus2019-11-29 DIGITAL TENS/MUSCLE WITH 7 MODES AND 24 PRESETS

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