The following data is part of a premarket notification filed by Leggero Llc with the FDA for Element Pediatric Wheelchair.
| Device ID | K182840 |
| 510k Number | K182840 |
| Device Name: | Element Pediatric Wheelchair |
| Classification | Wheelchair, Mechanical |
| Applicant | Leggero Llc P O Box 485 Burnet, TX 78611 |
| Contact | Gabriela Romero |
| Correspondent | Mike Johnson Philosopher's River LLC P O Box 106 Willow Creek, MT 59760 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-09 |
| Decision Date | 2019-04-29 |