FDA.reportPublic FDA data

Pathway Pain & Sensory Evaluation System

Primary DI
07290103039806
Brand
Pathway Pain & Sensory Evaluation System
Company
MEDOC LTD.
Model
Pathway
Catalog number
MO 00007-12
Device description
The Pathway Pain & Sensory Evaluation System is a computerized thermal stimulator designed for neurological and pain research. Pathway expands the fun
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NTUEvoked Potential Stimulator, Thermal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTUEvoked Potential Stimulator, ThermalNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052357000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052357000PATHWAY - ATS/CHEPSMedoc Ltd. Advanced Medical Systems2006-01-19NTU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290103039806PackageGS11In Commercial Distribution
07290103039301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290103039806072901030398067290103039806
07290103039301072901030393017290103039301

GMDN Terms#

Term, Definition table
TermDefinition
Thermotester, diagnosticA mains electricity (AC-powered) device designed to provide quantitative diagnostic evaluation of a patient's reaction to thermal stimuli, typically on the skin surface, by providing information on threshold to heat or cold perception. The device typically operates by gradually increasing the temperature to 42 - 50? Celsius. It is typically used to diagnose early diabetes mellitus, for phantom pain detection, neurological studies of thin fibre nerve systems, and also for pain threshold investigations.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600469191
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290103039011Medoc Main Station SoftwareMMSSW 000122023-06-20
07290103039066CoVasCoVasAS 002132023-06-20
07290103039073One Button Response UnitOBRUDT 000122023-06-20
07290103039219 Thermode CHEPSTSA 2AS 004202023-06-20
07290103039233Q-Sense Response UnitQ-SenseAS 004032023-06-20
07290103039240Q-Sense Base AssemblyQ-SenseAS 004002023-06-20
07290103039264Patient Response UnitPRUAS 002432023-06-20
07290103039653VSA 2 Hand HeldVSA 2MO 000172023-06-20
07290103039660VSA 2 Handheld deviceVSA 2 Handheld DeviceAS 004222023-06-20
07290103039677VSA 2 Hand-Leg supportVSA 2 Leg AS 004252023-06-20
07290103039820TSA 2 Air TSA 2 Air 2023-06-20
07290103039837TSA 2 Air TSA 2 Air AS 001892023-06-20
07290103039899TSA 2TSA 2AS 001702023-06-20
07290103039905TSA 2TSA 2MO 000152023-06-20
07290103039912Thermode 30X30 (TSA 2) TSA 2 30X30AS 001762023-06-20
07290103039929Thermode 16X16 (TSA 2) Thermode 16X16AS 001772023-06-20
07290103039936Thermode fMRI 30*30mm - including fMRI filterThermode fMRIAS 001782023-06-20
07290103039943Thermode fMRI 16X16mm - including fMRI filterfMRI ThermodeAS 001792023-06-20
07290103039950Thermode CHEPS fMRI CHEPSAS 004212023-06-20
07290103039967Thermode 6mm diameterTSA 2AS 001852023-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290103039301Pathway Pain & Sensory Evaluation SystemMEDOC LTD.NTU2016-09-24
07290103039318Contact Heat Evoked Potential StimulatorMEDOC LTD.NTU2016-09-24