← Back to catalogue
Pathway Pain & Sensory Evaluation System
FDA UDIClass II (US FDA UDI)
by Medoc Corp.
Identity
- Trade Name
- Pathway Pain & Sensory Evaluation System FDA UDI
- Generic Name
- Thermotester, diagnostic FDA UDI
- Device Name
- The Pathway Pain & Sensory Evaluation System is a computerized thermal stimulator designed for neurological and pain research. Pathway expands the functions offered by Medoc TSA-II, introducing new hardware and software capabilities to expand the quantitative investigation of human nociceptive pathways. The PATHWAY is a pain management and pain research system intended to be used for the quantitative assessment of small nerve fiber dysfunctions. It measures sensory thresholds such as cold and warm sensation and heat-induced pain. The Device includes: main unit, at least one probe/thermode and accessories. FDA UDI
- Model / Reference
- Pathway FDA UDI
- Description
- The Pathway Pain & Sensory Evaluation System is a computerized thermal stimulator designed for neurological and pain research. Pathway expands the functions offered by Medoc TSA-II, introducing new hardware and software capabilities to expand the quantitative investigation of human nociceptive pathways. The PATHWAY is a pain management and pain research system intended to be used for the quantitative assessment of small nerve fiber dysfunctions. It measures sensory thresholds such as cold and warm sensation and heat-induced pain. The Device includes: main unit, at least one probe/thermode and accessories. FDA UDI
Identifiers
- Catalog Number
- MO 00007-12 FDA UDI
- Primary DI / UDI-DI
- 07290103039301 FDA UDI
- 510(k) Number
- K052357 FDA UDI
- FDA Product Code
- NTU FDA UDI
- GMDN Term
- Thermotester, diagnostic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1870 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Thermotester, diagnostic
Pathway Pain & Sensory Evaluation System by Medoc Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thermotester, diagnostic.
- NEURO TOUCH — YOSTRA LABS PRIVATE LIMITED · Class I
- Thermode 30x30mm (Q-Sense) — Medoc Corp. · Class I
- Q-Sense Response Unit — Medoc Corp. · Class I
- Thermode 6mm diameter — Medoc Corp. · Class I
- Contact Heat Evoked Potential Stimulator — Medoc Corp. · Class I
- Thermode fMRI 16X16mm - including fMRI filter — Medoc Corp. · Class I
- Thermode CHEPS fMRI — Medoc Corp. · Class I
- Thermode 16X16 (TSA 2) — Medoc Corp. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medoc Corp.
Sources (1)
- FDA UDI 388e1e56-7f28-4ec9-8f13-3e4e20295ad2 35 fields · synced May 30, 2026