FDA.report

CHATTANOOGA

Primary DI
00888912296649
Brand
CHATTANOOGA
Company
DJO, LLC
Model
28501
Device description
APPLICATOR 5CM BLUE CALIBR
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IMIUltrasonic diathermy for use in applying therapeutic deep heat

Product Code Classifications

CodeDeviceSpecialtyClass
IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep HeatPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888912296649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888912296649008889122966498889122966490888912296649

GMDN Terms

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

Regulatory Flags

DUNS number
081840873
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00190446968344DJO SURGICALS-2019632026-03-16
00190446953685DJO SURGICALS-2019592026-02-17
00190446953708DJO SURGICALS-2019582026-02-17
00888912408691DJO SURGICAL800-05-0242023-01-18
00190446940920DJO SURGICALS-2019462025-11-18
00190446660453PROCARE155-81-974272025-07-23
00190446660576PROCARE155-81-971502025-07-23
00190446662686PROCARE155-BH-1942025-07-23
00190446660354PROCARE155-79-843002025-07-14
00190446660583PROCARE155-79-84100C2025-07-14
00190446662785PROCARE155-BH827102025-07-14
00190446662891PROCARE155-81-874802025-07-14
00190446662907PROCARE155-81-874902025-07-14
00190446662914PROCARE155-81-874602025-07-14
00190446662921PROCARE155-81-874702025-07-14
00190446662792PROCARE155-81-873022025-07-11
00190446662808PROCARE155-81-873032025-07-11
00190446662815PROCARE155-81-873052025-07-11
00190446662822PROCARE155-81-873072025-07-11
00190446662839PROCARE155-81-873082025-07-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
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
00810113682396ManaMedMANAMED INCIMI2022-06-20
17290110121782Opus System 110V ALMA LASERS LTD.IMI2020-02-20
00860001452532HF54, HorizonHILL LABORATORIES CO.IMI2020-02-04
00092237902530Therasound Evo 120VCOMPASS HEALTH BRANDS CORP.IMI2019-11-05
00092237902547CM4 Winner Evo Device - 120VCOMPASS HEALTH BRANDS CORP.IMI2019-11-05
00092237902554CM4 Winner Evo Device WITH HAMMERCOMPASS HEALTH BRANDS CORP.IMI2019-11-05
00092237901731Therasound EVO 3.5PCompass Richmar, LLCIMI2018-10-10
00092237901083Ultrasound AccessoriesCompass Richmar, LLCIMI2018-09-27