The following data is part of a premarket notification filed by Motion Concepts with the FDA for Trx Vertical Positioner.
Device ID | K023426 |
510k Number | K023426 |
Device Name: | TRX VERTICAL POSITIONER |
Classification | Wheelchair, Powered |
Applicant | MOTION CONCEPTS 84 CITATION DR. Concord, Ontario, CA L4k 3c1 |
Contact | David Ciolfe |
Correspondent | David Ciolfe MOTION CONCEPTS 84 CITATION DR. Concord, Ontario, 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 | 2002-10-11 |
Decision Date | 2002-11-21 |
Summary: | summary |