510(k) Exempt OTC - Can we sell this device on Amazon?

[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!

 

[Al Rosen]

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!

Read the limitations of 21cfr890.9. It may only be exempt if it is for Rx use and not OTC.

 

[Oslap]

Read the limitations of 21cfr890.9. It may only be exempt if it is for Rx use and not OTC.

Thanks for link, I've read it. Intended use of our device is to be sold OTC and used at home. Also, another device which is recognized by FDA and used this classification is being sold on Amazon. So now I'm confused how it can only be exempt if it's for Rx? Could you elaborate please? I've sent an email to FDA as well, let's see.

 

[Al Rosen]

Thanks for link, I've read it. Intended use of our device is to be sold OTC and used at home. Also, another device which is recognized by FDA and used this classification is being sold on Amazon. So now I'm confused how it can only be exempt if it's for Rx? Could you elaborate please? I've sent an email to FDA as well, let's see.

Just because someone is selling it on amazon, doesn't make it legal.

 

[Mark Meer]

...
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
...

I looked up the product code on the FDA Product Classification Database to confirm the regulation number.

I then looked up the cited regulation number (890.5670) on eCFR and the FDA CFR Search, and could not find it. The closest regulation appears to be §890.5660 (Therapeutic massager), which is Class I.

...might be something to clarify with the FDA...

 

[Al Rosen]

The device was approved through the de novo process. Note the CONDITIONS OF EXEMPTIONS in the attached K100934.