FDA.reportPublic FDA data

Applicator 9401

Primary DI
00816864020661
Brand
Applicator 9401
Company
METTLER ELECTRONICS CORP.
Model
9401
Catalog number
9401
Device description
940 applicator (Large size/ 1 & 3 MHz)
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
GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
IMGSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
LIHINTERFERENTIAL CURRENT THERAPY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep HeatPhysical Medicine2
LIHInterferential Current TherapyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071137000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071137000SONICATOR PLUS 940, MODEL ME940Mettler Electronics Corp.2007-08-01IMG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816864020661PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816864020661008168640206618168640206610816864020661

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy ultrasound system applicatorA hand-held component of a physical therapy ultrasound system that includes a transdcer designed to convert electric voltages into ultrasound energy [e.g., frequencies greater than 20 kilohertz (kHz)] and directs this energy into body tissues. The localized thermal and nonthermal effects generated by the ultrasonic energy is associated with increased blood flow in the treated area and is intended to accelerate tissue repair. The device is typically used with ultrasound coupling gels to ensure an adequate interface with the patient. This is a reusable device.

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
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
00816864020760Applicator 7335733573352016-09-15

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08032625828020GLOBUSDOMINO SRLLIH2024-09-04
B786SBM1AB0110actiTENSSUBLIMEDGZJ2024-04-24
20192253018360Uni-PatchCardinal Health 200, LLCGZJ2024-02-28
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