Product Classification

• Device: bed, hydraulic, adjustable hospital
• Regulation Description: Hydraulic adjustable hospital bed.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: FNK
• Premarket Review: Drug Delivery and General Hospital Devices, and Human Factors (DHT3C); Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
• Submission Type: 510(K) Exempt
• Regulation Number: 880.5110
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible

Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.

If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.

• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 6-321 IEC 60601-2-52 Edition 1.0 2009-12
  Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds [Including: Technical Corrigendum 1 (2010)]
• 6-483 IEC 60601-2-35 Edition 2.0 2020-09
  Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
• 6-489 IEC 60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION
  Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds

Third Party Review

Not Third Party Eligible