FDA.reportPublic FDA data

Auto*Therm 390

Primary DI
00816864020180
Brand
Auto*Therm 390
Company
METTLER ELECTRONICS CORP.
Model
ME 390
Catalog number
ME 390
Device description
Continuous and pulsed shortwave diathermy with capacitive applicators
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IMJDIATHERMY, SHORTWAVE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMJDiathermy, Shortwave, For Use In Applying Therapeutic Deep HeatPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042554000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042554000AUTO THERM 390, MODEL ME 390Mettler Electronics Corp.2004-10-08IMJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816864020180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816864020180008168640201808168640201800816864020180

GMDN Terms#

Term, Definition table
TermDefinition
Short-wave diathermy treatment system, professionalAn assembly of devices designed to provide a therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio-frequency (RF) bands of 13 megahertz (MHz) to 27.12 MHz. It typically consists of an electric generator and two electrodes (active and return) intended to be held on/near the patient. The device is intended to be operated by healthcare provider in a clinical setting, typically to treat pain, muscle spasms, and joint contractures; it is not used for surgery or to treat malignancies.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight15Pound

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Operating Temperture: 50-104 F
Storage Environment Temperature-40 Degrees Fahrenheit167 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(714)533-2221service@mettlerelectronics.com

Regulatory Flags#

DUNS number
008513913
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816864020210Sonicator Plus 920ME 920ME 9202016-09-15
00816864020227Sonicator Plus 930, 2 channelME 930ME 9302016-09-15
00816864020234Sonicator Plus 940, 4 channelME 940ME 9402016-09-15
00816864020241Sonicator Plus 992, 2 channelME 992ME 9922016-09-15
00816864020258Sonicator Plus 994, 4 channelME 994ME 9942016-09-15
00816864021682accufitaccufit2026-04-22
00816864020609Ultrasound Applicator 7410741074102016-09-15
00816864020616Ultrasound Applicator 7413741374132016-09-15
00816864020623Ultrasound Applicator 7431743174312016-09-15
00816864020630Applicator 7513751375132016-09-15
00816864020647Applicator 9201920192012016-09-15
00816864020654Applicator 9202920292022016-09-15
00816864020661Applicator 9401940194012016-09-15
00816864020678Applicator 9402940294022016-09-15
00816864020708Applicator 7001700170012016-09-15
00816864020715Applicator 7005700570052016-09-15
00816864020722Applicator 7107710771072016-09-15
00816864020739Applicator 7305730573052016-09-15
00816864020746Applicator 7310731073102016-09-15
00816864020753Applicator 7331733173312016-09-15

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Primary DI, Brand, Company table
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00850886008009Replexa+ DevicePROMEDTEK, INC.IMJ2019-07-08
00850886008016Replexa+ Treatment ApplicatorPROMEDTEK, INC.IMJ2019-07-08
B108703POENUS0100BTL-703BTL INDUSTRIES LIMITEDIMJ2019-04-16
00092237620397Richmar TheraTouch Drive Devilbiss HealthcareIMJ2019-02-08
04053815055174ThermoProZimmer MedizinSysteme GmbHIMJ2016-12-16
00888912187848CHATTANOOGADJO, LLCIMJ2016-09-15
00888912187855CHATTANOOGADJO, LLCIMJ2016-09-15
00888912187909CHATTANOOGADJO, LLCIMJ2016-09-15
00888912187916CHATTANOOGADJO, LLCIMJ2016-09-15
00888912188050CHATTANOOGADJO, LLCIMJ2016-09-15
00888912188685CHATTANOOGADJO, LLCIMJ2016-09-15
00888912253949CHATTANOOGADJO, LLCIMJ2016-09-15
00888912335645CHATTANOOGADJO, LLCIMJ2016-09-15
00816864020531Drum Applicator 3980METTLER ELECTRONICS CORP.IMJ2016-09-15
00888912187831CHATTANOOGADJO, LLCIMJ2016-09-12
00888912253772CHATTANOOGADJO, LLCIMJ2016-09-12
00858703006078Megapulse IIACCELERATED CARE PLUS CORPIMJ2016-08-16
00858703006085Megapulse III/OmniSWDACCELERATED CARE PLUS CORPIMJ2016-08-16