Freedom Designs, Inc.: FDA clearances and approvals
Freedom Designs, Inc. has 10 FDA 510(k) clearances (first 1994, latest 2015), across 1 product code in 1 review panel. Median 510(k) review time: 40 days. openFDA lists 1 product recall by a recalling firm named Freedom Designs, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 104 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | 10 | 10 |
Review panels
- Physical Medicine (10)
Most recent Freedom Designs, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151893 | P.R.O. CG Manual Wheelchair | IOR | 2015-10-22 | 104 |
| K080270 | MANUAL RIGID MOBILITY WHEELCHAIR | IOR | 2008-04-16 | 75 |
| K060926 | TRIPOD | IOR | 2006-05-19 | 45 |
| K040622 | FREEDOM HP | IOR | 2004-04-16 | 38 |
| K023574 | GIZMO | IOR | 2002-12-04 | 41 |
| K993640 | SPECTRUM LIBRE WHEELCHAIR | IOR | 1999-11-16 | 19 |
| K983859 | SPECTRUM SMALL FRY | IOR | 1998-11-25 | 30 |
| K983763 | SPECTRUM SPIRIT | IOR | 1998-11-23 | 28 |
| K952431 | SPECTRUM | IOR | 1995-06-22 | 29 |
| K944970 | SOLUTION | IOR | 1994-12-13 | 63 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2007-05-14.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Freedom Designs, Inc. have?
Freedom Designs, Inc. has 10 FDA 510(k) clearances (first 1994, latest 2015), across 1 product code in 1 review panel.
How long does FDA take to clear Freedom Designs, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Freedom Designs, Inc.'s cleared 510(k)s is 40 days.
What devices does Freedom Designs, Inc. make?
Its most frequent FDA product codes are IOR (Wheelchair, Mechanical, 10).
Has Freedom Designs, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Freedom Designs, Inc; the most recent began 2007-05-14. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 10 Freedom Designs, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IOR, Freedom Designs, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.