Auto*Therm 390 ME 390

GUDID 00816864020180

Continuous and pulsed shortwave diathermy with capacitive applicators

METTLER ELECTRONICS CORP.

Short-wave diathermy treatment system, professional
Primary Device ID00816864020180
NIH Device Record Key0e2fea2e-79fc-487a-85a3-5260b7d5b96b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAuto*Therm 390
Version Model NumberME 390
Catalog NumberME 390
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 Latexfalse
Labeled No Natural Rubber Latextrue
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

Weight15 Pound
Weight15 Pound
Weight15 Pound

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 167 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 167 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100816864020180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IMJDIATHERMY, SHORTWAVE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-15

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