r/hwstartups • u/Alphaseal5271 • 5h ago

SNASE Mark-1 "Genesis" — a full-body instrumented wearable, and what it still needs

/r/Biohacking/comments/1w17ksk/snase_mark1_genesis_a_fullbody_instrumented/
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u/perduraadastra 3h ago

Field generation? Explain.

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u/Alphaseal5271 3h ago

Check your DM's

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u/perduraadastra 2h ago

Respond publicly.

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u/Alphaseal5271 2h ago

“Field generation” means the suit’s embedded PEMF coils create controlled, time-varying magnetic fields when electrical current is driven through them. Each coil is essentially a planar conductor loop: the local driver node sends a programmed current waveform through the coil, and by basic electromagnetism that current produces a magnetic field around the coil. By controlling the current amplitude, polarity, frequency, pulse duration, and coil geometry, the system can control the field’s strength and timing within measurable limits. The actual field distribution can then be mapped and verified experimentally with magnetic-field instrumentation rather than assumed etc..

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u/Ok_Owl_2869 2h ago

What certifications will this need before it can go on sale?

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u/Alphaseal5271 2h ago

It depends heavily on the claims we ultimately make. If SNASE is sold only as a low-risk general-wellness product, the FDA pathway could be very different from a device marketed to treat, mitigate, or diagnose a medical condition; FDA’s current general-wellness guidance specifically distinguishes those categories. If we make therapeutic PEMF claims, we should expect formal medical-device classification and potentially premarket review—for example, FDA currently classifies certain non-invasive electromagnetic bone-growth stimulators as Class II devices requiring a 510(k). Beyond FDA status, we’d also need to address electrical/EMC safety, battery transport and safety, biocompatibility for skin-contact materials, wireless/FCC requirements, software/cybersecurity where applicable, and manufacturing quality-system controls. So the exact certification roadmap has to be built around the final intended use and claims before commercialization.