Bed, Manual

Device Code: 2563

Product Code(s): FNJ

Device Classification Information

• Device Type ID: 2563
• Device Name: Bed, Manual
• Regulation Description: Manual Adjustable Hospital Bed.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); General Hospital Devices Branch (GHDB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 880.5120 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: FNJ
• GMP Exempt: Yes
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized 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)]
• 6-390 IEC 80601-2-35 Edition 2.1 2016-04
  CONSOLIDATED VERSION Medical Electrical Equipment-Part 2-35: Particular Requirements For The Basic Safety And Essential Performance Of Heating Devices Using Blankets, Pads Or Mattresses And Intended For Heating In Medical Use [Including: Amendment 1 (2016)]

Total Product Life Cycle

• Device Type ID: 2563
• Device: Bed, Manual
• Product Code: FNJ
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Manual Adjustable Hospital Bed.
• CFR Regulation Number: 880.5120 [🔎]

Device Problems
Adverse Event Without Identified Device Or Use Problem	4
Use Of Device Problem	1
Fracture	1
Device Operates Differently Than Expected	1
Unintended Movement	1
Misassembly By Users	1
Positioning Problem	1
Total Device Problems	10

TPLC Last Update: 2019-04-02 20:14:44