Identity
- Trade Name
- Thermal Sensory Analazer FDA UDI
- Generic Name
- Thermotester, diagnostic FDA UDI
- Device Name
- The Thermal Sensory Analyzer TSA-II is a computer controlled device capable of generating and documenting response to highly repeatable thermal stimuli which 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 and accessories. FDA UDI
- Model / Reference
- TSA-II FDA UDI
- Description
- The Thermal Sensory Analyzer TSA-II is a computer controlled device capable of generating and documenting response to highly repeatable thermal stimuli which 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 and accessories. FDA UDI
Identifiers
- Catalog Number
- MO 00004 FDA UDI
- Primary DI / UDI-DI
- 07290103039103 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
Thermal Sensory Analazer by Medoc Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Thermotester, diagnostic.
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- 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 1e1c38a0-0e8d-4d78-a79f-b82b74ce09ed 35 fields · synced Jun 8, 2026