Extreme X8
Wheelchair, Powered
Magic Mobility
The following data is part of a premarket notification filed by Magic Mobility with the FDA for Extreme X8.
Pre-market Notification Details
| Device ID | K211574 |
| 510k Number | K211574 |
| Device Name: | Extreme X8 |
| Classification | Wheelchair, Powered |
| Applicant | Magic Mobility 3 International Court Scoreby, AU 3179 |
| Contact | Alex Suen |
| Correspondent | Michelle Rubin-onur AcKnowledge Regulatory Strategies, LLC 2251 San Diego Ave 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 | 2021-05-21 |
| Decision Date | 2021-07-09 |
Trademark Results [Extreme X8]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXTREME X8 97200577 not registered Live/Pending |
Sunrise Medical (US) LLC 2022-01-03 |
 EXTREME X8 79103454 not registered Dead/Abandoned |
RED MILAWA PTY LTD 2011-07-12 |
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