Compliance and Privacy
FCC & IC
ETL & ETLC – ANSI & AAMI
IEC & ISO Compliant - (60601-1, 60601-1-2 62304, 62366, ISO 14971, ISO 10993)
Additional Testing
Shock, vibration, altitude and temperature shock
Treatment Data: All treatments tracked and stored in the helmet’s SD card
Mobile Application
Compatibility iOS Compatible
Android compatibility expected in 2020
Wifi 802.11bgn
Bluetooth BLE 4.2
Compatible Streaming Services: Youtube, Spotify, iTunes
Device Failure Mode
ReGrow is designed to last for 5 years of standard use. The light from the VCSELs do not
fade or diminish over time. At the end of the laser’s life or if it fails for any other reason, the
red laser light will no longer shine out of ReGrow.
Expected Life of Your Device
ReGrow is a medical device made and tested under strict quality controls. The factory that
makes ReGrow has ISO 9001, ISO 14001 & ISO 13485. ReGrow has high quality, USA
made VCSELs Based on that rating and the durability of the components being used, the
expected life of your Regrow MD is 5 years of regular use. Please take time to read this
entire user manual before operating your device.
Electromagnetic Immunity Guidance
The following information is provided in accordance with IEC/EN 60601-1-2 and this device is compliant
with the standard.
Guidance and Declaration – Electromagnetic Emissions
The Regrow Helmet is intended for use in the electromagnetic environment specified
below. The customer or the user of the Regrow Helmet should assure that it is used in
such environment.
Emission Test
Compliance
Electromagnetic environment -
guidance