The following data is part of a premarket notification filed by Power Plus Mobility with the FDA for Supertilt Plus (stp).
Device ID | K221435 |
510k Number | K221435 |
Device Name: | SUPERTILT PLUS (STP) |
Classification | Wheelchair, Mechanical |
Applicant | Power Plus Mobility 50 Malcom Rd Guelph, CA N1K1A9 |
Contact | Jason Mohan |
Correspondent | Jason Mohan Power Plus Mobility 50 Malcom Rd Guelph, CA N1K1A9 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-05-17 |
Decision Date | 2022-10-28 |