The following data is part of a premarket notification filed by Electromedical Products, Inc. with the FDA for Alpha-stim Cs.
| Device ID | K903014 |
| 510k Number | K903014 |
| Device Name: | ALPHA-STIM CS |
| Classification | Cranial Electrotherapy Stimulator To Treat Depression |
| Applicant | ELECTROMEDICAL PRODUCTS, INC. 12591 CRENSHAW BLVD. Hawthorne, CA 90250 |
| Contact | Daniel Kirsch |
| Correspondent | Daniel Kirsch ELECTROMEDICAL PRODUCTS, INC. 12591 CRENSHAW BLVD. Hawthorne, CA 90250 |
| Product Code | JXK |
| CFR Regulation Number | 882.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-10 |
| Decision Date | 1992-05-12 |