The following data is part of a premarket notification filed by Magic Mobility with the FDA for Magic 360 Power Wheelchair.
Device ID | K203083 |
510k Number | K203083 |
Device Name: | Magic 360 Power Wheelchair |
Classification | Wheelchair, Powered |
Applicant | Magic Mobility 3 International Court Scoreby, AU 3179 |
Contact | Alex Suen |
Correspondent | Michelle Rubin-onur AcKnowlegde Regulatory Strategies, LLC 2251 San Diego Avenue, Suite B-257 San Diego, CA 92110 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-10-13 |
Decision Date | 2021-03-17 |