The following data is part of a premarket notification filed by Electromedical Products, Inc. with the FDA for Alpha-stim 350.
| Device ID | K881753 |
| 510k Number | K881753 |
| Device Name: | ALPHA-STIM 350 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | ELECTROMEDICAL PRODUCTS, INC. 12591 CRENSHAW BLVD. Hawthorne, CA 90250 |
| Contact | David Singer |
| Correspondent | David Singer ELECTROMEDICAL PRODUCTS, INC. 12591 CRENSHAW BLVD. Hawthorne, CA 90250 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-21 |
| Decision Date | 1988-08-30 |