Freedom Designs Inc
Simi Valley, CA, US
FREEDOM DESIGNS, INC. appears in FDA device records in Simi Valley, CA. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Freedom Designs Inc between 1994 and 2015. The busiest year on record is 1998, with 2. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1995 | 1 |
| 1998 | 2 |
| 1999 | 1 |
| 2002 | 1 |
| 2004 | 1 |
| 2006 | 1 |
| 2008 | 1 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K151893 | P.R.O. CG Manual Wheelchair | IOR | Substantially Equivalent | |
| K080270 | MANUAL RIGID MOBILITY WHEELCHAIR | IOR | Substantially Equivalent | |
| K060926 | TRIPOD | IOR | Substantially Equivalent | |
| K040622 | FREEDOM HP | IOR | Substantially Equivalent | |
| K023574 | GIZMO | IOR | Substantially Equivalent | |
| K993640 | SPECTRUM LIBRE WHEELCHAIR | IOR | Substantially Equivalent | |
| K983859 | SPECTRUM SMALL FRY | IOR | Substantially Equivalent | |
| K983763 | SPECTRUM SPIRIT | IOR | Substantially Equivalent | |
| K952431 | SPECTRUM | IOR | Substantially Equivalent | |
| K944970 | SOLUTION | IOR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2081283 | 2081283 | FREEDOM DESIGNS, INC. | 7801 S Jackson Rd, Pharr, TX 78577 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0137-2008 | 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. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain