# K171785: WowGoHealth Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Biotest Medical Corporation
- Decided: Sep 15, 2017 after 92 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K070585 (2007). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141351: Supercheck Plus Blood Glucose Monitoring System, Super Check Plus Multi Blood Glucose Monitoring System, Biotest Medical Corp. (2015) Summary page 4.

## Most influential descendants
- K213061: SuperCheck Pro Blood Glucose Monitoring System (2022), 0 descendants of its own

## Indications for use
The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) consists of the WowGoHealth Blood Glucose Monitor and the WowGoHealth Blood Glucose Test Strip. The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or forearm. The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) is intended to be used by a single person and should not be shared. The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).

Source page: https://510kreport.com/device/K171785
Methodology: https://510kreport.com/methodology