The following data is part of a premarket notification filed by Innovative Designer Products, Inc. with the FDA for Solitens Modified.
| Device ID | K913522 |
| 510k Number | K913522 |
| Device Name: | SOLITENS MODIFIED |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | INNOVATIVE DESIGNER PRODUCTS, INC. 175 ROCK RD. Glen Rock, NJ 07452 |
| Contact | Saul Liss |
| Correspondent | Saul Liss INNOVATIVE DESIGNER PRODUCTS, INC. 175 ROCK RD. Glen Rock, NJ 07452 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-26 |
| Decision Date | 1991-08-28 |