FDA.reportPublic FDA data

CHATTANOOGA

Primary DI
00190446780311
Brand
CHATTANOOGA
Company
DJO, LLC
Model
15-0161
Device description
G16 ULTRASOUND APPLICATOR 2 CM2 USA
Published
2023-09-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IMGStimulator, ultrasound and muscle, for use in applying therapeutic deep heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep HeatPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446780311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446780311001904467803111904467803110190446780311

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081840873
Device count
1
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446780601CHATTANOOGA81-50102023-04-25
00190446780618CHATTANOOGA81-50112023-04-25
00190446750598CHATTANOOGA47382022-09-02
00190446750604CHATTANOOGA47822022-09-02
00190446757214CHATTANOOGA4782-12022-09-02
00190446757221CHATTANOOGA4738-12022-09-02
00888912036627PROCARE79-892002022-08-22
00888912292856CHATTANOOGA2761-102016-09-15
00888912292863CHATTANOOGA2761-22016-09-15
00888912294249CHATTANOOGA2789-102016-09-15
00888912294256CHATTANOOGA2789-22016-09-15
00888912296977CHATTANOOGA28742016-09-15
00888912297110CHATTANOOGA28762016-09-15
00888912297295CHATTANOOGA28782016-09-15
00888912335652CHATTANOOGA39-07012016-09-15
00888912335669CHATTANOOGA39-07022016-09-15
00888912267588CHATTANOOGA20252026-03-31
00888912267618CHATTANOOGA20272026-03-31
00888912267625CHATTANOOGA20282026-03-31
00888912267632CHATTANOOGA20292026-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720618311139Sonopuls 494Enraf-Nonius B.V.IMG2025-02-11
00190446748427CHATTANOOGADJO, LLCIMG2023-10-27
00190446750611CHATTANOOGADJO, LLCIMG2023-10-27
00190446750628CHATTANOOGADJO, LLCIMG2023-10-27
00190446780304CHATTANOOGADJO, LLCIMG2023-09-04
00190446780328CHATTANOOGADJO, LLCIMG2023-09-04
00190446780335CHATTANOOGADJO, LLCIMG2023-09-04
00858703006139OmniVersaACCELERATED CARE PLUS CORPIMG2023-08-17
00850030915191RichmarSouth Dakota Partners Inc.IMG2023-08-02
00850030915214RichmarSouth Dakota Partners Inc.IMG2023-08-02
00850030915221RichmarSouth Dakota Partners Inc.IMG2023-08-02
00190446780601CHATTANOOGADJO, LLCIMG2023-04-25
00190446780618CHATTANOOGADJO, LLCIMG2023-04-25
00092237623817TheraTouch UX2Drive Devilbiss HealthcareIMG2022-09-07
00190446750598CHATTANOOGADJO, LLCIMG2022-09-02
00190446750604CHATTANOOGADJO, LLCIMG2022-09-02
00190446757214CHATTANOOGADJO, LLCIMG2022-09-02
00190446757221CHATTANOOGADJO, LLCIMG2022-09-02
08908008085413Johari Digital Healthcare Ltd.SYRMA JOHARI MEDTECH LIMITEDIMG2021-06-04
08908008085420Johari Digital Healthcare Ltd.SYRMA JOHARI MEDTECH LIMITEDIMG2021-06-04
00092237902523Winner Evo CM2 - 120VDrive Devilbiss HealthcareIMG2019-11-05
00092237901052CM4 Winner Evo Device - 220VDrive Devilbiss HealthcareIMG2018-09-27
00092237901069Winner Evo CM2 - 120VDrive Devilbiss HealthcareIMG2018-09-27
00092237901076Winner Evo CM2 - 220VDrive Devilbiss HealthcareIMG2018-09-27
00092237901120AutoSound Hands Free US ApplicatorDrive Devilbiss HealthcareIMG2018-09-27
00850958007619WINNER EVO PACKAGEDrive Devilbiss HealthcareIMG2016-11-21
00850958007909WINNER EVO PACKAGEDrive Devilbiss HealthcareIMG2016-11-21
00850958007916WINNER EVO PACKAGEDrive Devilbiss HealthcareIMG2016-11-21
00850958007923WINNER EVO PACKAGEDrive Devilbiss HealthcareIMG2016-11-21
00850958007930WINNER EVO PACKAGEDrive Devilbiss HealthcareIMG2016-11-21