FDA.reportPublic FDA data

CHATTANOOGA

Primary DI
00888912022095
Brand
CHATTANOOGA
Company
DJO, LLC
Model
2795
Device description
INTELECT XT 4CH,COMBO,US STD 5CM APPL W/CART
Published
2016-09-15
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
00888912022095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888912022095008889120220958889120220950888912022095

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy ultrasound systemAn assembly of devices designed to produce and deliver ultrasonic waves that penetrate tissues and produce both thermal and nonthermal (e.g., mechanical and cavitation) effects to treat pain (e.g., muscle, tendon, joint) and as an aid in the healing of soft-tissue injuries (e.g., ulcerations, bursitis). It typically consists of a radio-frequency (RF) generator (frequencies from one to three megahertz are typical), a cable that transmits the RF energy to the applicator, and an applicator including a piezoelectric transducer that applies the ultrasonic energy to the patient's tissues through the skin.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081840873
Device count
1
Serial number
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
00190446780311CHATTANOOGADJO, 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