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Vehicle, Motorized 3-Wheeled

Page Type
Product Code
Regulation Medical Specialty
Physical Medicine
Review Panel
Physical Medicine
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
890.3800
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 890.3800 Motorized three-wheeled vehicle

§ 890.3800 Motorized three-wheeled vehicle.

(a) Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.

(b) Classification. Class II (performance standards).

Vehicle, Motorized 3-Wheeled

Page Type
Product Code
Regulation Medical Specialty
Physical Medicine
Review Panel
Physical Medicine
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
890.3800
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 890.3800 Motorized three-wheeled vehicle

§ 890.3800 Motorized three-wheeled vehicle.

(a) Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.

(b) Classification. Class II (performance standards).