Prosthesis, Thigh Socket, External Component

Device Code: 5180

Product Code(s): ISS

Device Classification Information

• Device Type ID: 5180
• Device Name: Prosthesis, Thigh Socket, External Component
• Regulation Description: External Limb Prosthetic Component.
• Regulation Medical Specialty: Physical Medicine
• Review Panel: Physical Medicine
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Neurological And Physical Medicine Devices (DNPMD); Physical Medicine And Rehabilitation Devices Branch (PMDB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 890.3420 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: ISS
• 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: 5180
• Device: Prosthesis, Thigh Socket, External Component
• Product Code: ISS
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: External Limb Prosthetic Component.
• CFR Regulation Number: 890.3420 [🔎]

Device Problems
Torn Material	2
Total Device Problems	2

TPLC Last Update: 2019-04-02 21:01:39