The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Levo-stand-up Wheelchair.
Device ID | K790265 |
510k Number | K790265 |
Device Name: | LEVO-STAND-UP WHEELCHAIR |
Classification | Wheelchair, Standup |
Applicant | MARION LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IPL |
CFR Regulation Number | 890.3900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-02-06 |
Decision Date | 1979-02-13 |