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Freedom Designs, Inc.

Country not established FDA establishment FEI 2081283

Devices
10
Registrations
FDA
FDA recalls
1

Catalogue10

Newest first, rows 1-10 of 10

  • Spectrum Ref K952431

    Class I
    Active 510(k) 510(k) I
  • Spectrum Small Fry Ref K983859

    Class I
    Active 510(k) 510(k) I
  • Solution Ref K944970

    Class I
    Active 510(k) 510(k) I
  • Spectrum Spirit Ref K983763

    Class I
    Active 510(k) 510(k) I
  • P.R.O. CG Manual Wheelchair Ref K151893

    Class I
    Active 510(k) 510(k) I
  • Manual Rigid Mobility Wheelchair Ref K080270

    Class I
    Active 510(k) 510(k) I
  • Gizmo Ref K023574

    Class I
    Active 510(k) 510(k) I
  • Spectrum Libre Wheelchair Ref K993640

    Class I
    Active 510(k) 510(k) I
  • Tripod Ref K060926

    Class I
    Active 510(k) 510(k) I
  • Freedom Hp Ref K040622

    Class I
    Active 510(k) 510(k) I

Company details

FDA FEI number
2081283
Address
7801 S Jackson Rd, Pharr, TX, 78577

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

  • 2007

    • 14 May 2007 Z-0137-2008 Unclassified (pre-2012) Terminated Tip-over hazard; the Anti tipper may fail/break and the wheel chair could tip over. Distribution: Nationwide: including states of AL, CA, FL, CO, GA, KS, LA, MI, MS, NC, OH, TN, TX, and VA Submission number: K060926

Frequently asked questions

How many devices does FREEDOM DESIGNS, INC. have in the registry?

The registry currently lists 10 devices for FREEDOM DESIGNS, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list FREEDOM DESIGNS, INC.'s devices?

Among its 10 most recently registered devices, FREEDOM DESIGNS, INC. has devices listed in FDA 510(k) (10 devices).

What risk classes do FREEDOM DESIGNS, INC.'s devices fall under?

Among its 10 most recently registered devices, the classes recorded for FREEDOM DESIGNS, INC.'s devices are Class I. Each device page shows its own class and authorisation.

Are there FDA recall records for FREEDOM DESIGNS, INC.?

FDA recall records list 1 recall initiated by FREEDOM DESIGNS, INC., the most recent initiated on 2007-05-14. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from FREEDOM DESIGNS, INC. in the registry?

The most recently registered devices listed for FREEDOM DESIGNS, INC. include SPECTRUM, SPECTRUM SMALL FRY, SOLUTION and SPECTRUM SPIRIT.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company.