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U.S. Department of Health and Human Services

Product Classification

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Device bath, hydro-massage
Regulation Description Immersion hydrobath.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeILJ
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 890.5100
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 Immersion Hydrobaths
Third Party Review
Accredited Persons

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