Permanently Mounted Wheelchair Platform Lift
The Permanently Mounted Wheelchair Platform Lift is a medical device providing a guided platform to move a person with impaired mobility, with or without a wheelchair, from one level to another. It falls under the Physical Medicine medical specialty and is classified as a Class 2 device under regulation 890.3930, requiring 510(k) premarket notification. These permanently installed lifts are used in homes and facilities to improve accessibility for wheelchair users and others with mobility impairments. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PCE
- Device Class
- FDA class 2
- Regulation Number
- 890.3930
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
Definition
Intended for medical purposes to provide a guided platform to move a person with impaired mobility, with or without a wheelchair, from one level to another.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K122206 | GARAVENTA X3 INCLINED PLATFORM LIFT | Mar 21, 2013 | Substantially Equivalent | Garaventa (Canada) Ltd [Dba Garaventa Lift] |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.