Decision Date2022-09-20
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
JO CUMPLAY Personal Lubricant is a medical device manufactured by CC Wellness, LLC. It received FDA 510(k) clearance on 2022-09-20 under approval number K221908. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the JO CUMPLAY Personal Lubricant?
JO CUMPLAY Personal Lubricant is a medical device that received FDA 510(k) clearance on 2022-09-20. It is manufactured by CC Wellness, LLC. The 510(k) number is K221908.
When was JO CUMPLAY Personal Lubricant approved by the FDA?
JO CUMPLAY Personal Lubricant received FDA 510(k) clearance on 2022-09-20, under approval number K221908.
What company makes JO CUMPLAY Personal Lubricant?
JO CUMPLAY Personal Lubricant is manufactured by CC Wellness, LLC.
What is the FDA product code for JO CUMPLAY Personal Lubricant?
The FDA product code for JO CUMPLAY Personal Lubricant is NUC.
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Official Source
View on FDA Database →
Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.