The following data is part of a premarket notification filed by Levo Usa with the FDA for Levo Compact Lc.
| Device ID | K963816 | 
| 510k Number | K963816 | 
| Device Name: | LEVO COMPACT LC | 
| Classification | Wheelchair, Standup | 
| Applicant | LEVO USA BLEICHEWEG 5 Dottikon, CH Ch-5605 | 
| Contact | Thomas Raeber | 
| Correspondent | Thomas Raeber LEVO USA BLEICHEWEG 5 Dottikon, CH Ch-5605  | 
| Product Code | IPL | 
| CFR Regulation Number | 890.3900 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1996-09-23 | 
| Decision Date | 1996-10-30 |