The following data is part of a premarket notification filed by Levo Usa with the FDA for Levo Compact-easy Lce.
Device ID | K973951 |
510k Number | K973951 |
Device Name: | LEVO COMPACT-EASY LCE |
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 | 1997-10-16 |
Decision Date | 1997-12-23 |