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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) Exempt
Regulation Number 890.5100
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: FDA intends to propose exempting these devices from premarket notification pursuant to the criteria at sections 510(l) and 510(m) of the FD&C Act, subject to limitations on exemption criteria found in .9 of the associated classification regulation. Until the publication of a final rule or order exempting these devices from 510(k), FDA does not intend to enforce compliance with 510(k) requirements for these devices. FDA does not expect manufacturers to submit 510(k)s for these devices during this time period.
Guidance Document
  • Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Immersion Hydrobaths
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons

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