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Oslap
Hi,
we will be registering with FDA and listing our medical device to be sold on Amazon. It is a Class II medical device with a 510(k) Exempt:
Device massager, therapeutic, to internally massage trigger points in the pelvic floor musculature
Definition Rectal or vaginal use manual therapeutic massager device to massage irritable, sore trigger points (trps) in the pelvic floor musculature in order to reduce internal pelvic floor trigger point sensitivity
Product Code OSD
Submission Type 510(K) Exempt
Regulation Number 890.5670
Device Class 2
GMP Exempt? No
My question is, can we sell this device on Amazon since it is an Exempt or do we need some sort of OTC approval first?
Thanks!
we will be registering with FDA and listing our medical device to be sold on Amazon. It is a Class II medical device with a 510(k) Exempt:
Device massager, therapeutic, to internally massage trigger points in the pelvic floor musculature
Definition Rectal or vaginal use manual therapeutic massager device to massage irritable, sore trigger points (trps) in the pelvic floor musculature in order to reduce internal pelvic floor trigger point sensitivity
Product Code OSD
Submission Type 510(K) Exempt
Regulation Number 890.5670
Device Class 2
GMP Exempt? No
My question is, can we sell this device on Amazon since it is an Exempt or do we need some sort of OTC approval first?
Thanks!