# K042350: Tes-1 Constant Voltage Electrical Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Cadwell Laboratories, Inc.
- Decided: Nov 3, 2004 after 65 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Cadwell TES-1 constant voltage electrical stimulator is intended for cortical stimulation. The TES-1 is intended for intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency. The Cadwell TES-1 Constant Voltage Stimulator is an accessory to the Cadwell Cascade Intra-operative monitoring system only. It is not a stand-alone device nor is it compatible with other systems.

Source page: https://510kreport.com/device/K042350
Methodology: https://510kreport.com/methodology