FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
SUPER CHAIR FOR KIDS BY ORION
K Number: K103073
·
Decision Jan 3, 2011
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
458
Applicant Total
5
Review Days
77
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Basic Information
- Device Name
- SUPER CHAIR FOR KIDS BY ORION
- K Number
- K103073
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Future Mobility Healthcare, Inc.
- Date Received
- October 18, 2010
- Decision Date
- January 3, 2011
- 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 Future Mobility Healthcare, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K130788 | CAPELLA | Dec 5, 2013 | Substantially Equivalent |
| K102031 | GALAXY LITE | Oct 20, 2010 | Substantially Equivalent |
| K101277 | ORION II (HEAVY DUTY 350 LBS AND 500 LBS) | Jun 4, 2010 | Substantially Equivalent |
| K061010 | FUTURE MOBILITY HEALTHCARE INC. ORION II WHEELCHAIR AND STELLATO MECHANICAL WHEELCHAIR | May 23, 2006 | Substantially Equivalent |