COMFYCOMBPLUS COMFYCOMBOPLUS, COMFYCOMBOPLUS-JETT, COMFYCOMBOPLU

GUDID 10816924020249

DIGITAL TENS/MUSCLE WITH 7 MODES AND 24 PRESETS

TENSPRODUCTS, INC.

Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID10816924020249
NIH Device Record Key087ff86a-de46-4366-ba3e-bc3b08668d52
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOMFYCOMBPLUS
Version Model NumberCOMFYCOMBOPLUS
Catalog NumberCOMFYCOMBOPLUS, COMFYCOMBOPLUS-JETT, COMFYCOMBOPLU
Company DUNS121251883
Company NameTENSPRODUCTS, 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
GS100816924020242 [Primary]
GS100816924020372 [Package]
Contains: 00816924020242
Package: KIT- WITH 4040TC [1 Units]
In Commercial Distribution
GS100816924020730 [Package]
Contains: 00816924020242
Package: KIT-WITH KWTS22-TP [1 Units]
In Commercial Distribution
GS100816924020778 [Package]
Contains: 00816924020242
Package: KIT-WITH KWTS22-MFR [1 Units]
In Commercial Distribution
GS110816924020249 [Package]
Contains: 00816924020372
Package: CASE- WITH 4040TC [32 Units]
In Commercial Distribution
GS110816924020775 [Package]
Contains: 00816924020778
Package: CASE-WITH KWTS22-MFR [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

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