Chair, Adjustable, Mechanical

Device Code: 5116

Product Code(s): INN

Device Classification Information

• Device Type ID: 5116
• Device Name: Chair, Adjustable, Mechanical
• Regulation Description: Mechanical Chair.
• 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: 890.3100 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: INN
• 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: 5116
• Device: Chair, Adjustable, Mechanical
• Product Code: INN
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Mechanical Chair.
• CFR Regulation Number: 890.3100 [🔎]

Device Problems
Break	5
Improper Or Incorrect Procedure Or Method	5
Adverse Event Without Identified Device Or Use Problem	4
Latch	2
Detachment Of Device Component	2
Misassembly By Users	2
Mechanical Jam	1
Mechanical Problem	1
Device Slipped	1
Belt	1
Use Of Device Problem	1
Structural Problem	1
Unstable	1
Fracture	1
Total Device Problems	28

Recalls
Manufacturer		Recall Class	Date Posted
1	Invacare Corporation	II	Jul-09-2014
2	Winco Mfg., LLC	II	Aug-14-2015

TPLC Last Update: 2019-04-02 21:00:31