The following data is part of a premarket notification filed by Action Manufacturing Inc. with the FDA for Action Trackchair.
Device ID | K181908 |
510k Number | K181908 |
Device Name: | Action Trackchair |
Classification | Wheelchair, Powered |
Applicant | Action Manufacturing Inc. 1105 Lake Road Marshall, MN 56258 |
Contact | Alan Macht |
Correspondent | Alan Macht Action Manufacturing Inc. 1105 Lake Road P.O. Box 620 Marshall, MN 56258 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-07-17 |
Decision Date | 2018-12-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ACTION TRACKCHAIR 77913599 not registered Dead/Abandoned |
Swenson, Timmy R. 2010-01-17 |