System, Isokinetic Testing And Evaluation

Device Code: 5061

Product Code(s): IKK

Device Classification Information

• Device Type ID: 5061
• Device Name: System, Isokinetic Testing And Evaluation
• Regulation Description: Isokinetic Testing And Evaluation System.
• 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: 890.1925 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: IKK
• 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: 5061
• Device: System, Isokinetic Testing And Evaluation
• Product Code: IKK
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Isokinetic Testing And Evaluation System.
• CFR Regulation Number: 890.1925 [🔎]

Device Problems
None	2
Adverse Event Without Identified Device Or Use Problem	2
Use Of Device Problem	1
Improper Or Incorrect Procedure Or Method	1
Cable	1
Device Handling Problem	1
Total Device Problems	8

Recalls
Manufacturer		Recall Class	Date Posted
1	Interactive Motion Technologies, Inc.	II	Nov-02-2015
2	MedX Holdings, Inc.	II	Jan-07-2015

TPLC Last Update: 2019-04-02 20:59:34