ST10 Progr. Evoked Response Stimulator
by Teca, Inc.
510(k) K822744
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK822744 | Date3 Nov 1982 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GWF
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1870
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The ST10 Progr. Evoked Response Stimulator is an electrical stimulator device designed to apply an electrical stimulus to a patient via skin electrodes. It is used for the purpose of measuring the evoked response.
This device is manufactured by Teca, Inc. and received FDA 510(k) clearance under K822744.
Other devices from Teca, Inc.
Questions
AI-generated answers, 22 Sep 2026
What is the primary purpose of the ST10 Progr. Evoked Response Stimulator?
This device is designed to apply an electrical stimulus to a patient through the use of skin electrodes. It is specifically intended for the measurement of evoked responses.
Who is the manufacturer of this stimulator?
The ST10 Progr. Evoked Response Stimulator is manufactured by Teca, Inc.
What is the regulatory status of this device?
The device received FDA 510(k) clearance under K822744. It was processed through a traditional submission route and classified under the neurology advisory committee.