Wireless Tuning Device
emPOWER - em4
Device Description
A portable, non-dedicated, and commonly hand-held computing device intended for the download/running of medical software to input, process and/or display data. It typically includes a microprocessor [central processing unit (CPU)], a display screen, and a keyboard and/or touchscreen integrated into one unit in the form of a laptop, tablet, palmtop or other hand-held (including smartphone) device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: ISW
Device Name: Assembly, Knee/Shank/Ankle/Foot, External
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: PM
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 890.3500
Third Party Flag: N
Medical Specialty: PM
Device IdentifiersDevice Id: B155EM40
Device Type: Primary
DeviceId Issuing Agency: HIBCC
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A