Data / Medical devices / United States / ATZ Manufacturing
ATZ Manufacturing: FDA-registered device maker in Marshall, MN, United States, 3 510(k) clearances
ATZ Manufacturing is registered with the FDA (registration 3014653196) in Marshall, MN, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 10, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014653196
- Address
- 1105 Lake Rd, Marshall, MN, United States, 56258
- Owner or operator
- ATZ Manufacturing (10057813)
- Roles
- Manufacturer
- First device listed
- May 29, 2018
- Registered through
- 2026
- Brand names listed
- Action Trackchair EAGLE, Action Trackchair HAWK, Action Trackstander FALCON
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Wheelchair, Powered | ITI | 2 | Manufacturer | accessdata.fda.gov |
| Wheelchair, Standup | IPL | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 10, 2022 | K202728 | Action Trackchair Hawk | IPL | Substantially Equivalent | Action Manufacturing, Inc. | accessdata.fda.gov |
| December 3, 2018 | K181908 | Action Trackchair | ITI | Substantially Equivalent | Action Manufacturing, Inc. | accessdata.fda.gov |
| January 12, 2018 | K163451 | Action Trackstander models TR1816, TR1820, TR2016, and TR2020 | IPL | Substantially Equivalent | Action Manufacturing, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 10, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.