The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for Tes-1 Constant Voltage Electrical Stimulator.
| Device ID | K042350 |
| 510k Number | K042350 |
| Device Name: | TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
| Contact | Chris Bolkan |
| Correspondent | Chris Bolkan CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-30 |
| Decision Date | 2004-11-03 |