The following data is part of a premarket notification filed by Permobil Ab with the FDA for Explorer Mini.
| Device ID | K190682 |
| 510k Number | K190682 |
| Device Name: | Explorer Mini |
| Classification | Wheelchair, Standup |
| Applicant | Permobil AB Box 120 S-861 23 Timra, SE |
| Contact | Ivan Fernandez |
| Correspondent | Ivan Fernandez Permobil AB Box 120 S-861 23 Timra, SE |
| Product Code | IPL |
| CFR Regulation Number | 890.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-18 |
| Decision Date | 2020-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17330818000993 | K190682 | 000 |