FDA.reportPublic FDA data

CHATTANOOGA

Primary DI
00888912025379
Brand
CHATTANOOGA
Company
DJO, LLC
Model
78047
Device description
APPLICATOR 5CM ASSY
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IMIUltrasonic diathermy for use in applying therapeutic deep heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep HeatPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888912025379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888912025379008889120253798889120253790888912025379

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

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
08800016213034PLASONICHironic Co., ltd.IMI2026-03-18
00850033615227Echo Ultrasound Device (PRC) THERMOTEK, INC.IMI2026-02-23
00850033615258Echo Ultrasound Device (PRC)THERMOTEK, INC.IMI2026-02-23
00850033615289Echo Ultrasound Device (USA)THERMOTEK, INC.IMI2026-02-23
00850033615340Echo Ultrasound Device (USA)THERMOTEK, INC.IMI2026-02-23
00850033615371Echo BOX, DRESSING & GEL POD PACK, USND, PRCTHERMOTEK, INC.IMI2026-02-23
00850033615388Echo CTN, DRESSINGS, USND, PRC, QTY 4 BOXESTHERMOTEK, INC.IMI2026-02-23
00850033615425Echo Ultra Sound Gel Pods, CartonTHERMOTEK, INC.IMI2026-02-23
00850033615487Echo Ultra Sound Gel Pod, SingleTHERMOTEK, INC.IMI2026-02-23
00850033615500Echo APPLICATOR, SINGLE, USNDTHERMOTEK, INC.IMI2026-02-23
00850033615517Echo POWER SUPPLY, CORD, SINGLE, USNDTHERMOTEK, INC.IMI2026-02-23
00850033615531Echo BELT CLIP, DEVICE PRTCTR, SNGL,USNDTHERMOTEK, INC.IMI2026-02-23
00850033615555Echo ARM STRAP, DEVICE PRTCTR, SNG, USNDTHERMOTEK, INC.IMI2026-02-23
00850033615562Echo GEL, TUBE, SINGLE, USNDTHERMOTEK, INC.IMI2026-02-23
00850033615586echoRx, MANUAL, USER, SINGLE, USNDTHERMOTEK, INC.IMI2026-02-23
00850033615593echoRx, GUIDE,QUICK START,SNGL,USNDTHERMOTEK, INC.IMI2026-02-23
00850033615623Echo CTN, DRESSINGS, USND, USA, QTY 4 BOXESTHERMOTEK, INC.IMI2026-02-23
00850033615630Echo BOX, DRESSING & GEL POD PACK, USND, USATHERMOTEK, INC.IMI2026-02-23
00810113682778ManaMed Transducer Holder PatchManamed, Inc.IMI2025-09-11
00810113682754ManaMed Transducer Fixation StrapManamed, Inc.IMI2025-09-11
00810113682761ManaMed Transducer Fixation StrapManamed, Inc.IMI2025-09-11
00850998008546ManaMed Transducer Holder PatchManamed, Inc.IMI2025-09-11
08720618311108Sonopuls 190Enraf-Nonius B.V.IMI2025-02-11
08720618311221Sonopuls 190Enraf-Nonius B.V.IMI2025-02-11
00850030915191RichmarSouth Dakota Partners Inc.IMI2023-08-02
00850030915214RichmarSouth Dakota Partners Inc.IMI2023-08-02
00850030915221RichmarSouth Dakota Partners Inc.IMI2023-08-02
07290110122317Accent Prime System 120V For Inc.ALMA LASERS LTD.IMI2022-11-22
07290110122324Accent Prime UltraSpeed Applicator for Inc.ALMA LASERS LTD.IMI2022-11-22
07290110122331Accent Prime MiniSpeed Applicator for Inc.ALMA LASERS LTD.IMI2022-11-22