Thanks for the reply iab. The product is Class 1 and is similar to a weighted vest that Occupational Therapists use with patients. I’m not sure on the 501k exempt status, though. QTP meaning quality testing protocol?
Thanks for the reply iab. The product is Class 1 and is similar to a weighted vest that Occupational Therapists use with patients. I’m not sure on the 501k exempt status, though. QTP meaning quality testing protocol?