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What I'm saying is that adaptive furniture is likely a registered class II medical device which goes through FDA approval. So the bed isn't 10K, but (a portion) the FDA registration is. The consequences of failing to register something that qualifies as medical devices are 1) fines 2) payments to anyone harmed and/or 3) time in federal prison.
Sure you could easily "disrupt" the market, but the market could easily disrupt the rest of your life.
Restraints are 100% a medical device and I would highly doubt you would either be allowed to purchase or be reimbursed for one that's not approved.
Edited to add: https://www.registrarcorp.com/blog/medical-devices/medical-device-registration/fda-class-ii-medical-devices/ A quick explainer (marketing from a business that helps companies register devices) since the FDA website is ... not super clear nor helpful.
Huh TIL thank you