Product Code: PCE FDA class 2 21 CFR 890.3930

Permanently Mounted Wheelchair Platform Lift

Physical Medicine

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.

510(k)s
1
FEI Numbers
12
Registration Numbers
12
Unique Applicants
1
Years Active

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

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

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Related 510(k) Clearances

This FDA classification is associated with 1 510(k) clearance via K numbers.

K Number Device Name
K122206 GARAVENTA X3 INCLINED PLATFORM 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.