Wearables · Hazloc Labs

Wearables Compliance Stack: Safety, RF Exposure, and Materials

Wearables fail late when teams treat them like tiny IoT boards. Skin contact, RF exposure, sweat, and battery proximity change the evidence set.

Stack layers

Layer	Watch-outs
RF / RED / FCC	Antenna next to body → SAR / RF exposure conditions
Product safety	Charging, batteries, accessible parts
Materials / biocompatibility	Skin contact plastics, nickel, allergies; Prop 65 in US
IP / durability	Sweat, wash claims — test what you advertise
Claims boundary	Wellness vs medical device classification

Actions before soft tooling

1. Write the intended use carefully — “diagnoses X” is a different universe from “tracks steps.”
2. Pick exposure condition (wrist, chest, head) with the RF lab early.
3. Qualify skin-contact materials and colorants, not just structural plastics.
4. Plan charger and cable as part of the system EMC/safety sample.

FAQ

Is FCC modular Wi-Fi enough?

Body-worn hosts often need RF exposure evaluation even with modular radios. Budget for it.

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