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510(k) K943789

POWER WHEELCHAIR CONVERSION KIT by Alber Technologies, Inc. — Product Code ITI

Clearance Details

Decision
SN ()
Decision Date
November 8, 1994
Date Received
August 3, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wheelchair, Powered
Device Class
Class II
Regulation Number
890.3860
Review Panel
PM
Submission Type

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets “mobility to persons restricted to a sitting position” to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility. NOTE: This type of device is not intended to climb stairs (see product code: IMK).

Other clearances by Alber Technologies, Inc.

  • K920105 — SCALAMOBIL (August 6, 1992)

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