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U.S. Department of Health and Human Services

Product Classification

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Device exerciser, measuring
Regulation Description Measuring exercise equipment.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeISD
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Neurotherapueutic Devices Branch (PNDB)
Submission Type 510(k)
Regulation Number 890.5360
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Exercise Equipment
Third Party Review
Accredited Persons

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