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
PCE Permanently Mounted Wheelchair Platform Lift