Essential TENS System

GUDID 10754756740006

ESSENTIAL MEDICAL SUPPLY INC

Analgesic transcutaneous electrical nerve stimulation system
Primary Device ID10754756740006
NIH Device Record Key745d53f3-c109-477b-8d7a-5e5ac19dedb3
Commercial Distribution StatusIn Commercial Distribution
Brand NameEssential TENS System
Version Model NumberS1000
Company DUNS189331325
Company NameESSENTIAL MEDICAL SUPPLY INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone407-770-0710
Emailmichael.hoepner@essentialmedicalsupply.com
Phone407-770-0710
Emailmichael.hoepner@essentialmedicalsupply.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100754756740009 [Primary]
GS110754756740006 [Package]
Contains: 00754756740009
Package: [30 Units]
In Commercial Distribution

FDA Product Code

GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-23
Device Publish Date2017-04-11

Devices Manufactured by ESSENTIAL MEDICAL SUPPLY INC

10754756740006 - Essential TENS System2019-10-23
10754756740006 - Essential TENS System2019-10-23
20754756740010 - TENS Electrode Set2019-10-23
10754756750005 - Essential Digital TENS System2019-10-23
00754756380007 - Endurance Standard Alternating Pressure Pump2018-03-29
00754756380014 - Endurance Standard Alternating Pressure Pump & Pad Combo2018-03-29
10754756388000 - Endurance Standard Alternating Pressure Bubble Pad2018-03-29
00754756388010 - Endurance Standard Alternating Pressure Bubble Pad w/Flaps2018-03-29
00754756390006 - Endurance Deluxe Alternating Pressure Pump2018-03-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.