The following data is part of a premarket notification filed by Levo Usa with the FDA for Levo Active-easy Lae.
| Device ID | K971873 |
| 510k Number | K971873 |
| Device Name: | LEVO ACTIVE-EASY LAE |
| 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 | 1997-05-20 |
| Decision Date | 1997-07-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613045036762 | K971873 | 000 |