FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPECTRUM LIBRE WHEELCHAIR
K Number: K993640
·
Decision Nov 16, 1999
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
458
Applicant Total
10
Review Days
19
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Basic Information
- Device Name
- SPECTRUM LIBRE WHEELCHAIR
- K Number
- K993640
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Freedom Designs, Inc.
- Date Received
- October 28, 1999
- Decision Date
- November 16, 1999
- Product Code
- IOR
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | FDA class 1 | Physical Medicine |
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FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Freedom Designs, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K151893 | P.R.O. CG Manual Wheelchair | Oct 22, 2015 | Substantially Equivalent |
| K080270 | MANUAL RIGID MOBILITY WHEELCHAIR | Apr 16, 2008 | Substantially Equivalent |
| K060926 | TRIPOD | May 19, 2006 | Substantially Equivalent |
| K040622 | FREEDOM HP | Apr 16, 2004 | Substantially Equivalent |
| K023574 | GIZMO | Dec 4, 2002 | Substantially Equivalent |
| K983859 | SPECTRUM SMALL FRY | Nov 25, 1998 | Substantially Equivalent |
| K983763 | SPECTRUM SPIRIT | Nov 23, 1998 | Substantially Equivalent |
| K952431 | SPECTRUM | Jun 22, 1995 | Substantially Equivalent |
| K944970 | SOLUTION | Dec 13, 1994 | Substantially Equivalent |