MY TSF HOMECARE APP ANDROID

MY TSF HOMECARE APP ANDROID
SMART TSF - 71075403

A software program intended to be used by a layperson at home to receive data from a noninvasive, patient-worn, wireless monitor/sensor to display, record, and assist in analysis and healthcare provider reporting of the collected clinical data, typically for continuous monitoring and optional communication with a clinician. It may enable configuration of alert notifications and is typically installed on an off-the-shelf, portable, computerized device (e.g., smartphone, tablet); it is not dedicated to bedside monitoring.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OSN

Device Name: Software For Diagnosis/Treatment

Device Class: 2

Physical State: Custom written or off the shelf software intended to be used with an orthopedic trauma device

Definition: Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Software operated by the manufacturer or end user intended to diagnose or treat an orthopedic condition

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Musculoskeletal system

Regulation Number: 888.3030

Third Party Flag: N

Medical Specialty: OR

Device Id: 00885556808016

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A