Platform, Force-measuring

Device Code: 5202

Product Code(s): KHX

Device Classification Information

• Device Type ID: 5202
• Device Name: Platform, Force-measuring
• Regulation Description: Force-measuring Platform.
• 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: 890.1575 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: KHX
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 4-185 ANSI S3.45-2009 (Reaffirmed 2014)
  American National Standard Procedures For Testing Basic Vestibular Function

Total Product Life Cycle

• Device Type ID: 5202
• Device: Platform, Force-measuring
• Product Code: KHX
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Force-measuring Platform.
• CFR Regulation Number: 890.1575 [🔎]

Device Problems
Unintended System Motion	1
Application Program Freezes, Becomes Nonfunctional	1
Total Device Problems	2

TPLC Last Update: 2019-04-02 21:02:03