The following data is part of a premarket notification filed by Kalaco Scientific, Inc. with the FDA for Transcranial Electrotherapy Stimulator-a, Model Tesa-1.
| Device ID | K024377 |
| 510k Number | K024377 |
| Device Name: | TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1 |
| Classification | Stimulator, Cranial Electrotherapy |
| Applicant | KALACO SCIENTIFIC, INC. 131 GLENN WAY SUITE 7 San Carlos, CA 94070 |
| Contact | Grace Bartoo |
| Correspondent | Grace Bartoo KALACO SCIENTIFIC, INC. 131 GLENN WAY SUITE 7 San Carlos, CA 94070 |
| Product Code | JXK |
| CFR Regulation Number | 882.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-31 |
| Decision Date | 2003-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B788KS02000 | K024377 | 000 |