The following data is part of a premarket notification filed by Magic Mobility with the FDA for Frontier Series Power Wheelchairs.
Device ID | K213090 |
510k Number | K213090 |
Device Name: | Frontier Series Power Wheelchairs |
Classification | Wheelchair, Powered |
Applicant | Magic Mobility 3 International Court Scoreby, AU 3179 |
Contact | Jill Mckechnie |
Correspondent | Matthieu Kirkland Acknowledge 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 | 2021-09-24 |
Decision Date | 2021-11-19 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00016958059724 | K213090 | 000 |
00016958059717 | K213090 | 000 |