FDA.reportPublic FDA data

Drum Applicator 3980

Primary DI
00816864020531
Brand
Drum Applicator 3980
Company
METTLER ELECTRONICS CORP.
Model
3980
Catalog number
3980
Device description
14 cm diameter drum applicator
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00816864020531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816864020531008168640205318168640205310816864020531

GMDN Terms#

Term, Definition table
TermDefinition
Short-wave diathermy treatment system generatorA component of a short-wave therapeutic diathermy system designed to generate electromagnetic (EM) energy in the radio-frequency (RF) bands of 13 megahertz (MHz) to 27.12 MHz applied transcutaneously to provide a deep heat within specific volumes of the body. The energy generated by this device is typically conducted using electrodes placed on the patient's skin across the area to be treated; the energy is passed between the electrode poles to treat pain, muscle spasms, and joint contractures.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No
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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00850886008016Replexa+ Treatment ApplicatorPROMEDTEK, INC.IMJ2019-07-08
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00092237620397Richmar TheraTouch Drive Devilbiss HealthcareIMJ2019-02-08
04053815055174ThermoProZimmer MedizinSysteme GmbHIMJ2016-12-16
00888912187848CHATTANOOGADJO, LLCIMJ2016-09-15
00888912187855CHATTANOOGADJO, LLCIMJ2016-09-15
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00888912253949CHATTANOOGADJO, LLCIMJ2016-09-15
00888912335645CHATTANOOGADJO, LLCIMJ2016-09-15
00816864020180Auto*Therm 390METTLER 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