The following data is part of a premarket notification filed by Action Manufacturing Inc. with the FDA for Action Trackchair Hawk.
Device ID | K202728 |
510k Number | K202728 |
Device Name: | Action Trackchair Hawk |
Classification | Wheelchair, Standup |
Applicant | Action Manufacturing Inc. 1105 Lake Road Marshall, MN 56258 |
Contact | Alan Macht |
Correspondent | Alan Macht Action Manufacturing Inc. 1105 Lake Road 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 | 2020-09-18 |
Decision Date | 2022-02-10 |