The following data is part of a premarket notification filed by Motion Concepts with the FDA for Modular Power Positioning System.
Device ID | K150574 |
510k Number | K150574 |
Device Name: | Modular Power Positioning System |
Classification | Wheelchair, Powered |
Applicant | MOTION CONCEPTS 84 CITATION DR. Unit #1 Concord, CA L4k 3c1 |
Contact | Dona Bhamra |
Correspondent | Dona Bhamra MOTION CONCEPTS 84 CITATION DR. Unit #1 Concord, CA L4k 3c1 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-03-06 |
Decision Date | 2015-06-30 |
Summary: | summary |