FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
GALAXY LITE
K Number: K102031
·
Decision Oct 20, 2010
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
458
Applicant Total
5
Review Days
93
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Basic Information
- Device Name
- GALAXY LITE
- K Number
- K102031
- 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
- July 19, 2010
- Decision Date
- October 20, 2010
- 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 |
Similar 510(k) Clearances
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ICON 35; ICON 45; ICON 60; ICON 30FAF
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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 |
| K103073 | SUPER CHAIR FOR KIDS BY ORION | Jan 3, 2011 | 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 |