Last synced on 18 April 2025 at 11:05 pm

Stroller, Adaptive

Page Type
Product Code
Regulation Medical Specialty
Physical Medicine
Review Panel
Physical Medicine
Submission Type
510(K)
Device Classification
Class 1
Regulation Number
890.3850
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 890.3850 Mechanical wheelchair

§ 890.3850 Mechanical wheelchair.

(a) Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

(b) Classification. Class I (general controls).

Stroller, Adaptive

Page Type
Product Code
Regulation Medical Specialty
Physical Medicine
Review Panel
Physical Medicine
Submission Type
510(K)
Device Classification
Class 1
Regulation Number
890.3850
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 890.3850 Mechanical wheelchair

§ 890.3850 Mechanical wheelchair.

(a) Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

(b) Classification. Class I (general controls).