FDA.reportPublic FDA data

Titronics

Primary DI
00860447001714
Brand
Titronics
Company
TITRONICS RESEARCH & DEVELOPMENT COMPANY
Model
Tytron C-7000
Device description
The C-7000 is indicated for use in detecting, measuring, recording, and graphing the skin surface temperature on both sides of the spine of adults and children by chiropractors. It is to be used before and after therapy is rendered as part of monitoring the patient's response to care, similar to a common thermometer
Published
2019-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCSDevice, Temperature Measurement, Direct Contact, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCSDevice, Temperature Measurement, Direct Contact, PoweredNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974208000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974208000TYTRON C-3000Titronics Research & Development Co.1998-02-03HCS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860447001714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860447001714008604470017148604470017140860447001714

GMDN Terms#

Term, Definition table
TermDefinition
Thermographic cameraA camera intended to measure and display differences in temperature, usually shown by colour differences, in humans or objects. Differences in temperature may be used for examination and diagnosis applications (e.g., in skin conditions, vascular disorders, or breast malignancies). This device may be stand-alone or part of a thermographic system.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure700 millibar1025 millibar
Handling Environment Humidity0 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Handling Environment Temperature21 Degrees Celsius25 Degrees Celsius
Storage Environment Atmospheric Pressure700 millibar1025 millibar
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
319-545-7377chris@titronics.com

Regulatory Flags#

DUNS number
073499345
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860447001738TitronicsC-50002024-01-18
00860447001707TitronicsTytron C-50002019-01-21
00860447001721TitronicsTy-tROM G-2000 2019-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00853818007477MyoVision SoftwarePRECISION BIOMETRICS INCHCS2022-11-10
00853818007460MyoVision Wirefree SystemPRECISION BIOMETRICS INCHCS2021-05-17
00853818007422SERIES-5 MyoVision Full SystemPRECISION BIOMETRICS INCHCS2021-02-28
00853818007439SERIES-5 MyoVision ScanVisionPRECISION BIOMETRICS INCHCS2021-02-28
00853818007446SERIES-5 MyoVision ScanVisionPRECISION BIOMETRICS INCHCS2021-02-28
00853818007453SERIES-5 MyoVision FlexVision SystemPRECISION BIOMETRICS INCHCS2021-02-28
00853818007415MyoVision Wirefree SystemPRECISION BIOMETRICS INCHCS2021-01-05
00860447001707TitronicsTITRONICS RESEARCH & DEVELOPMENT COMPANYHCS2019-01-21
00853818007392MyoVision SoftwarePRECISION BIOMETRICS INCHCS2018-04-18
00853818007354MyoVision Wirefree SystemPRECISION BIOMETRICS INCHCS2017-12-18
00853818007378USB Charging CablePRECISION BIOMETRICS INCHCS2017-12-13
00853818007347MyoVision Wirefree SystemPRECISION BIOMETRICS INCHCS2017-11-03
00853818007330USB ChargerPRECISION BIOMETRICS INCHCS2017-02-20
00853818007309Myovision Charging CablePRECISION BIOMETRICS INCHCS2016-12-31
00853818007316Flexlite Charging CablePRECISION BIOMETRICS INCHCS2016-12-31
00853818007323USB 2.0 Cable (WireFree)PRECISION BIOMETRICS INCHCS2016-12-31
00853818007262DynaVision BeltsPRECISION BIOMETRICS INCHCS2016-12-19
00853818007224ScanVision electrodesPRECISION BIOMETRICS INCHCS2016-12-13
00853818007187USB 2.0 Cable (WireFree)PRECISION BIOMETRICS INCHCS2016-12-13
00853818007194Power Cable for PB-204 (EU - Type E/F) (WireFree)PRECISION BIOMETRICS INCHCS2016-12-13
00853818007200Power Cable for PB-204 (North American - Type B) (WireFree)PRECISION BIOMETRICS INCHCS2016-12-13
00853818007217Power Cable for PB-204 (UK/Ireland - Type G) (WireFree)PRECISION BIOMETRICS INCHCS2016-12-13
00853818007255QuickScan Pads & Electrodes PackPRECISION BIOMETRICS INCHCS2016-12-13
00853818007279MyoPad VaultPRECISION BIOMETRICS INCHCS2016-12-13
00853818007286Dynamic Lead Wire SetPRECISION BIOMETRICS INCHCS2016-12-13
00853818007293Power Supply for WireFreePRECISION BIOMETRICS INCHCS2016-12-13
00853818007125DynaVision Dynamic sEMG ElectrodesPRECISION BIOMETRICS INCHCS2016-12-07
00853818007156QuickScan PadsPRECISION BIOMETRICS INCHCS2016-12-07
00853818007057MyoVision SoftwarePRECISION BIOMETRICS INCHCS2016-11-27
00853818007064MyoVision SoftwarePRECISION BIOMETRICS INCHCS2016-11-27