Device, Transfer, Patient, Manual

Device Code: 2557

Product Code(s): FMR

Device Classification Information

• Device Type ID: 2557
• Device Name: Device, Transfer, Patient, Manual
• Regulation Description: Manual Patient Transfer Device.
• 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: 880.6785 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: FMR
• GMP Exempt: Yes
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 2557
• Device: Device, Transfer, Patient, Manual
• Product Code: FMR
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Manual Patient Transfer Device.
• CFR Regulation Number: 880.6785 [🔎]

Device Problems
Off-Label Use	8
Adverse Event Without Identified Device Or Use Problem	2
Fail-Safe Problem	1
Device Dislodged Or Dislocated	1
Fracture	1
Inflation Problem	1
Device Operates Differently Than Expected	1
Installation-Related Problem	1
Device Handling Problem	1
Break	1
Mechanical Problem	1
Total Device Problems	19

TPLC Last Update: 2019-04-02 20:14:38