The following data is part of a premarket notification filed by Waismed Ltd with the FDA for Nio+ Adult.
| Device ID | K211968 |
| 510k Number | K211968 |
| Device Name: | NIO+ Adult |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | WaisMed Ltd 10 Amal St. Afek Industrial Park Rosh Ha'ayin, IL 4809234 |
| Contact | Shifra Hoch |
| Correspondent | Shifra Hoch WaisMed Ltd 10 Amal St. Afek Industrial Park Rosh Ha'ayin, IL 4809234 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-24 |
| Decision Date | 2021-07-22 |