FDA Product code of a heated foot spa?

cosmeticqg

Starting to get Involved
Can someone help me find the right code to use for registering a heated foot spa? The spa is heated to approx 40degC. I can't find a code that matches perfectly and would appreciate any recommendations. Thank you!
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Yodon makes the correct point. Unless you are diagnosing, monitoring or treating or preventing a health condition its not a medical devices. It also needs to be a diagnosable health condition to show evidence its safe and effective.
 

cosmeticqg

Starting to get Involved
@Ed Panek and @yodon, thank you. Theueis that my company sells foot baths that have a massage function. These are considered medical devices. The problem is that I do not see heated foot baths listed anywhere. Based on your feedback, it seems that since we do not have a massager feature and do not include medical claims, the product is not considered a medical device. Would that be a correct assessment?
FDA Product code of a heated foot spa?
 

yodon

Leader
Super Moderator
I won't speak for @Ed Panek , but if I were you, I wouldn't take my word for it. :) I'd enlist the help of a regulatory expert to do a little research and write a justification why you're not a medical device (or why you are and what product code). A few hundred $$ now could save you a lot of grief later. Sometimes, devices require multiple predicates (like one with that massages and one that heats - NOTE: I'm not suggesting your device is like this) and a regulatory expert will be able to corral all that information and give you the best guidance.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
I won't speak for @Ed Panek , but if I were you, I wouldn't take my word for it. :) I'd enlist the help of a regulatory expert to do a little research and write a justification why you're not a medical device (or why you are and what product code). A few hundred $$ now could save you a lot of grief later. Sometimes, devices require multiple predicates (like one with that massages and one that heats - NOTE: I'm not suggesting your device is like this) and a regulatory expert will be able to corral all that information and give you the best guidance.
Agreed. If you are involving investors in the project they would like a clear and evidence-based decision stating its medical device status prior to investing Millions into it.
 

chris1price

Trusted Information Resource
One other thought, check out your competitors. If there are products on the market, look them up in the FDA databases. If the product is listed it will tell you the product codes. If the competitor is not listed, it doesn't mean you shouldn't be, but it will give you a good idea.
 
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