The following data is part of a premarket notification filed by Medical Consultants Intl. Ltd. with the FDA for Model Sw-103 Solitans Stimulator.
| Device ID | K904264 |
| 510k Number | K904264 |
| Device Name: | MODEL SW-103 SOLITANS STIMULATOR |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | MEDICAL CONSULTANTS INTL. LTD. 59 OXFORD PLACE Glen Rock, NJ 07452 |
| Contact | Saul Liss |
| Correspondent | Saul Liss MEDICAL CONSULTANTS INTL. LTD. 59 OXFORD PLACE 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 | 1990-09-18 |
| Decision Date | 1991-05-09 |