Sling, Arm

Device Code: 5072

Product Code(s): ILI

Device Classification Information

• Device Type ID: 5072
• Device Name: Sling, Arm
• Regulation Description: Arm Sling.
• 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: 890.3640 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: ILI
• GMP Exempt: Yes
• 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: 5072
• Device: Sling, Arm
• Product Code: ILI
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Arm Sling.
• CFR Regulation Number: 890.3640 [🔎]

Device Problems
Insufficient Information	2
Adverse Event Without Identified Device Or Use Problem	2
Total Device Problems	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Owens & Minor Distribution, Inc.	II	Dec-22-2016

TPLC Last Update: 2019-04-02 20:59:46