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TD-7301 Spirometer is intended to monitor Peak Expiratory Flow (PEF), Forced Expiratory Volume (FEV) in home and professional healthcare environments. The device is designed for use with children over 5 years old, adolescent and adult subjects.

The TD-7301 Spirometer is a portable and handheld electronic spirometer used to measure expired Peak Expiratory Flow (PEF), Forced Expiratory Volume in one second (FEV1), Forced Expiratory Volume in six second (FEV6) and their ratio (FEV1/FEV6). The users can transfer their measurement results from the TD-7301 Spirometer to iFORA smart on their mobile devices via Bluetooth. The iFORA smart provide an overview of users record with historical data and trend graph. The TD-7301 Spirometer hardware is identical to the TD-7301 Peak Flow Meter cleared under K222810 (reference device).

The TD-5010 Lancing Device and TD-5084 Sterile Lancets are intended to obtain capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, and the forearm. The single-use TD-5084 Sterile Lancets are to be used with the reusable TD-5010 Lancing Device that is to be cleaned and disinfected between each use, and then the TD-5084 Sterile Lancets are to be disposed of. For use only on a single patient in a home setting. Not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

The TD-5010 Lancing Device uses compatible TD-5084 Sterile Lancets to obtain a drop of blood from a fingertip or alternative sites. The TD-5010 Lancing Device consists of two components: (1)TD-5010 Lancing Device (2) Alternative Site Testing (AST) Cap