Data / Medical devices / United States / Freedom Designs, Inc.
Freedom Designs, Inc.: FDA-registered device maker in Pharr, TX, United States, 3 510(k) clearances
Freedom Designs, Inc. is registered with the FDA (registration 2081283) in Pharr, TX, United States. It lists 8 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 22, 2015. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2081283
- Address
- 7801 S Jackson Rd, Pharr, TX, United States, 78577
- Owner or operator
- Invacare Corporation dba Invacare America (1525712)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 23, 1992
- Registered through
- 2026
- Brand names listed
- 120A, Dual Motor, Power Controller, 120A, Dual Motor, Power Controller with Lights and 2 Actuator Channels, 2-Channel Actuator Module, 2D Dynamic Footrest Hanger, 4-Channel Actuator Module, 4-Switch Proximity, 4-way expansion block (harness for expandable systems), Adjustable Rear Anti-Tipper and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Wheelchair | KNO | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Armrest, Wheelchair | IML | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Board, Lap, Wheelchair | IMX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Components, Wheelchair | KNN | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Cushion, Wheelchair | IMP | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Device, Anti-Tip, Wheelchair | IMR | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Footrest, Wheelchair | IMM | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Wheelchair, Mechanical | IOR | 1 | Complaint file establishment, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| October 22, 2015 | K151893 | P.R.O. CG Manual Wheelchair | IOR | Substantially Equivalent | Freedom Designs, Inc. | accessdata.fda.gov |
| December 4, 2002 | K023574 | GIZMO | IOR | Substantially Equivalent | Freedom Designs, Inc. | accessdata.fda.gov |
| June 22, 1995 | K952431 | SPECTRUM | IOR | Substantially Equivalent | Freedom Designs, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 14, 2007 | 44928 | Not yet classified | Terminated | Freedom Designs TriPod w/Anti tipper Manual Wheelchair, Models Numbers: TriPod, Tripod LT and TriPod Pediatric LT with Trailing Anti-Tipper-Caster-Axle Link, Freedom Designs Incorporated, Simi Valley, CA 93065 | Tip-over hazard; the Anti tipper may fail/break and the wheel chair could tip over. | accessdata.fda.gov |
Compare with other makers
- All makers of Footrest, Wheelchair
- All makers of Armrest, Wheelchair
- All makers of Device, Anti-Tip, Wheelchair
- All makers of Components, Wheelchair
- All makers of Wheelchair, Mechanical
- All makers of Accessories, Wheelchair
Updated October 22, 2015. 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.