The following data is part of a premarket notification filed by Numedtec, Inc. with the FDA for Support Pump.
| Device ID | K904486 |
| 510k Number | K904486 |
| Device Name: | SUPPORT PUMP |
| Classification | Device, External Penile Rigidity |
| Applicant | NUMEDTEC, INC. 29475 HAWTHORNE LN. Libertyville, IL 60048 |
| Contact | Peter Miller |
| Correspondent | Peter Miller NUMEDTEC, INC. 29475 HAWTHORNE LN. Libertyville, IL 60048 |
| Product Code | LKY |
| CFR Regulation Number | 876.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-02 |
| Decision Date | 1990-12-14 |