Spectrum

by Freedom Designs, Inc. 510(k)

Active United States

510(k) K952431

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK952431	Date22 Jun 1995Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K952431
FDA Product Code: IOR

Device Class: Class I
Regulation: 21 CFR Part 890.3850
Advisory Committee: Physical Medicine
FDA Decision: SESE Substantially Equivalent

Other devices from Freedom Designs, Inc.

Spectrum Small Fry

Class I
Solution

Class I
Spectrum Spirit

Class I
P.R.O. CG Manual Wheelchair

Class I
Manual Rigid Mobility Wheelchair

Class I
Gizmo

Class I

See all devices from Freedom Designs, Inc. →