The following data is part of a premarket notification filed by Permobil Ab with the FDA for Permobil M300 / M400.
| Device ID | K103477 |
| 510k Number | K103477 |
| Device Name: | PERMOBIL M300 / M400 |
| Classification | Wheelchair, Powered |
| Applicant | PERMOBIL AB BOX 120 Timra, SE S-861 23 |
| Contact | Jan Astrom |
| Correspondent | Jan Astrom PERMOBIL AB BOX 120 Timra, SE S-861 23 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-26 |
| Decision Date | 2011-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17330818198768 | K103477 | 000 |
| 17330818123401 | K103477 | 000 |