JO CUMPLAY Personal Lubricant— 510(k) K221908
Substantially EquivalentCC Wellness, LLC
FDA 510(k) clearance K221908 for JO CUMPLAY Personal Lubricant, Substantially Equivalent on 2022-09-20. Applicant: CC Wellness, LLC. Device class: 2.
Clearance details
- Applicant
- CC Wellness, LLC
- Product code
- Code NUC
- Device class
- Class 2
- Regulation
- 21 CFR 884.5300
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Valencia, CA, US
Recent devices under product code NUC
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view all- K232091 — JO Coconut Hybrid Cooling Personal Lubricant
- K232090 — JO Coconut Hybrid Warming Personal Lubricant
- K230674 — JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114
- K212885 — Actively Trying Personal Lubricant Rose Scented
- K212705 — Actively Trying Personal Lubricant Unfragrance
Adverse events under product code NUC
product code NUC- Other
- 8
- Total
- 8
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.