The following data is part of a premarket notification filed by Mobius Mobility with the FDA for Ibot Personal Mobility Device (ibot Pmd).
Device ID | K210920 |
510k Number | K210920 |
Device Name: | IBOT Personal Mobility Device (iBOT PMD) |
Classification | Wheelchair, Stair Climbing |
Applicant | Mobius Mobility 540 Commercial St. Suite 310 Manchester, NH 03101 |
Contact | Joseph Sullivan |
Correspondent | Joseph Sullivan Mobius Mobility 540 Commercial St. Suite 310 Manchester, NH 03101 |
Product Code | IMK |
CFR Regulation Number | 890.3890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-03-29 |
Decision Date | 2021-06-16 |