Sys Stim 294 ME 294

GUDID 00816864020173

Powered muscle stimulator, four channel neuromuscular stimulator, multi-function

METTLER ELECTRONICS CORP.

Physical therapy transcutaneous electrical stimulation system, line-powered
Primary Device ID00816864020173
NIH Device Record Key4f0b3b1e-5565-478d-a370-1df62f6e44b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSys Stim 294
Version Model NumberME 294
Catalog NumberME 294
Company DUNS008513913
Company NameMETTLER ELECTRONICS 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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(714)533-2221
Emailservice@mettlerelectronics.com
Phone+1(714)533-2221
Emailservice@mettlerelectronics.com
Phone+1(714)533-2221
Emailservice@mettlerelectronics.com

Device Dimensions

Weight9.4 Pound
Weight9.4 Pound
Weight9.4 Pound

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Operating Temperture: 50-104 F
Special Storage Condition, SpecifyBetween 0 and 0 *Operating Temperture: 50-104 F

Device Identifiers

Device Issuing AgencyDevice ID
GS100816864020173 [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 Number4
Public Version Date2019-05-23
Device Publish Date2016-09-15

Devices Manufactured by METTLER ELECTRONICS CORP.

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00816864020111 - TENS 2102019-10-23 Two-channel battery-operated TENS unit
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00816864020135 - TENS 2122019-10-23 Two-channel digial TENS device with LCD display
00816864020142 - TENS*STIM 2112019-10-23 Stimulator, muscle, powered, for muscle conditioning
00816864020401 - Trio*Stim 2152019-10-23 Stimulator, nerve, transcutaneous, for pain relief
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