The following data is part of a premarket notification filed by Action Manufacturing Inc. with the FDA for Action Trackstander Models Tr1816, Tr1820, Tr2016, And Tr2020.
| Device ID | K163451 |
| 510k Number | K163451 |
| Device Name: | Action Trackstander Models TR1816, TR1820, TR2016, And TR2020 |
| Classification | Wheelchair, Standup |
| Applicant | Action Manufacturing Inc. 1105 Lake Rd. Marshall, MN 56258 |
| Contact | Alan Macht |
| Correspondent | Alan Macht Action Manufacturing Inc. 1105 Lake Rd. Marshall, MN 56258 |
| Product Code | IPL |
| CFR Regulation Number | 890.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-08 |
| Decision Date | 2018-01-12 |