Identity
- Trade Name
- Q-Sense Thermal Sensory Analazer FDA UDI
- Generic Name
- Thermotester, diagnostic FDA UDI
- Device Name
- The Q-Sense Thermal Sensory Analyzer is a QST (Quantitative Sensory Testing) device including advanced software package designed for clinical use and advance research in the field of Pain Management. The Q-Sense is a pain management and pain research intended to be used for the quantitative assessment of small nerve fiber dysfunctions. It measures sensory thresholds such as the sensation of warmth, cold, heat-induced pain and cold-induced pain. The Device includes: main unit, one thermode/probe and accessories. FDA UDI
- Model / Reference
- Q-Sense FDA UDI
- Description
- The Q-Sense Thermal Sensory Analyzer is a QST (Quantitative Sensory Testing) device including advanced software package designed for clinical use and advance research in the field of Pain Management. The Q-Sense is a pain management and pain research intended to be used for the quantitative assessment of small nerve fiber dysfunctions. It measures sensory thresholds such as the sensation of warmth, cold, heat-induced pain and cold-induced pain. The Device includes: main unit, one thermode/probe and accessories. FDA UDI
Identifiers
- Catalog Number
- MO 00013 FDA UDI
- Primary DI / UDI-DI
- 07290103039202 FDA UDI
- 510(k) Number
- K922052 FDA UDI
- FDA Product Code
- LQW FDA UDI
- GMDN Term
- Thermotester, diagnostic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 882.1200 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
Category: Thermotester, diagnostic
Q-Sense Thermal Sensory Analazer by Medoc Corp. — Class I — 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
Cleared under the same submission
K922052 also covers:
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 I | Pending data |
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Manufacturer
- Manufacturer
- Medoc Corp.
Sources (1)
- FDA UDI ce287f6c-0d55-4bd1-b7cf-a6c4fe929521 35 fields · synced Jun 1, 2026