Product Classification

• Device: bath, sitz, powered
• Regulation Description: Immersion hydrobath.
• Regulation Medical Specialty: Physical Medicine
• Review Panel: Physical Medicine
• Product Code: ILM
• 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

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.