Armrest, Wheelchair

Device Code: 5095

Product Code(s): IML

Device Classification Information

• Device Type ID: 5095
• Device Name: Armrest, Wheelchair
• Regulation Description: Wheelchair Component.
• Regulation Medical Specialty: Physical Medicine
• Review Panel: Physical Medicine
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Neurological And Physical Medicine Devices (DNPMD); Physical Medicine And Rehabilitation Devices Branch (PMDB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 890.3920 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: IML
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 5095
• Device: Armrest, Wheelchair
• Product Code: IML
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Wheelchair Component.
• CFR Regulation Number: 890.3920 [🔎]

Device Problems
Adverse Event Without Identified Device Or Use Problem	2
Use Of Device Problem	1
Improper Or Incorrect Procedure Or Method	1
Total Device Problems	4

TPLC Last Update: 2019-04-02 21:00:10