Identifiers
- 510(k) Number
- K141872 FDA 510(k)
- FDA Product Code
- GZO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1540 FDA 510(k)
- Regulation Number
- 882.1540 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sudoscan is a galvanic skin response measurement device designed to evaluate sudomotor function by assessing sweat gland activity. It quantifies small nerve fiber integrity within the peripheral nervous system, particularly those innervating sweat glands, to aid in neurological assessments.
The device is supplied as a standalone system comprising a computer and four electrodes for hand and foot placement. It is intended for single-use applications in clinical settings, with no regulatory indication of sterility or MRI compatibility specified. Authorised under FDA 510(k) and MDD frameworks, it operates under Class II classification and is regulated under FDA code 882.1540.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: IMPETO MEDICAL HOMEPAGE - Impeto Medical, SUDOSCAN, Impeto Medical is now Sudoscan!, About Impeto Medical - Sudoscan
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K141872 | Class II | Active |
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Manufacturer
- Manufacturer
- Impeto Medical, Inc.
Sources (2)
- FDA 510(k) K141872 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 20, 2026