FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GARAVENTA X3 INCLINED PLATFORM LIFT
K Number: K122206
·
Decision Mar 21, 2013
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
0
Applicant Total
1
Review Days
239
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Basic Information
- Device Name
- GARAVENTA X3 INCLINED PLATFORM LIFT
- K Number
- K122206
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 890.3930
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Garaventa (Canada) Ltd [Dba Garaventa Lift]
- Date Received
- July 25, 2012
- Decision Date
- March 21, 2013
- Product Code
- PCE
- 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 |
|---|---|---|---|
| PCE | Permanently Mounted Wheelchair Platform Lift | FDA class 2 | Physical Medicine |