JO CUMPLAY Personal Lubricant
FDA 510(k) K221908 · CC Wellness, LLC
510(k) numberK221908
Submission
- Device name
- JO CUMPLAY Personal Lubricant
- Applicant
- CC Wellness, LLC
Valencia, CA, US - Received
- June 30, 2022
- Decision date
- September 20, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NUC – Lubricant, Personal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5300
- Specialty
- Obstetrics/Gynecology
This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.
Other 510(k)s with product code NUC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253989 | HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based…NUC · Traditional | Maxigen Biotech, Inc. | 09/03/2026SE |
| K261905 | BUM OilNUC · Traditional | Bumlicious, LLC (DBA Bumlicious) | 08/07/2026SE |
| K261177 | PINKSLIP Water-Based Personal Lubricant and MoisturizerNUC · Traditional | Pinkslip, LLC | 07/09/2026SE |
| K261909 | Plum Vagiceuticals Vaginal Moisturizing SuppositoriesNUC · Traditional | PCCA, Inc. | 07/06/2026SE |
| K254011 | Flow Water-Based Personal LubricantNUC · Traditional | LBDO Group, Inc. | 06/22/2026SE |
| K261292 | PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)NUC · Traditional | PR Personal Care Laboratories | 06/11/2026SE |
| K252914 | Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)NUC · Traditional | Hathor Professional Skincare , Ltd. | 06/09/2026SE |
| K260068 | pjur NATURE Touch, 100 mlNUC · Traditional | Pjur Group Luxembourg S.A. | 05/21/2026SE |
| K254101 | Julva Velvé Water-Based Personal LubricantNUC · Traditional | Golden Isles Medical, Inc. | 04/16/2026SE |
| K260007 | Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA…NUC · Traditional | Hudi Pharma Srl | 04/01/2026SE |
More from Hudi Pharma Srl
| 510(k) | Device | Decision |
|---|---|---|
| K232091 | JO Coconut Hybrid Cooling Personal LubricantNUC · Traditional | 10/22/2023SE |
| K232090 | JO Coconut Hybrid Warming Personal LubricantNUC · Traditional | 10/11/2023SE |
| K230674 | JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant…NUC · Traditional | 05/08/2023SE |
| K212885 | Actively Trying Personal Lubricant Rose ScentedPEB · Traditional | 02/11/2022SE |
| K212705 | Actively Trying Personal Lubricant UnfragrancePEB · Traditional | 02/09/2022SE |
| K210986 | H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife…NUC · Traditional | 06/10/2021SE |
| K210972 | H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for…NUC · Traditional | 06/10/2021SE |
| K200894 | Agape Cooling Personal LubricantNUC · Traditional | 07/02/2020SE |
| K200602 | Premium Cooling Personal Lubricant, Premium Anal Cooling LubricantNUC · Traditional | 06/03/2020SE |
| K200457 | Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One WarmingNUC · Traditional | 05/22/2020SE |
Questions and answers
When was JO CUMPLAY Personal Lubricant cleared by the FDA?
JO CUMPLAY Personal Lubricant (K221908) received a 510(k) decision of Substantially Equivalent on September 20, 2022, 82 days after the submission was received.
What is the product code of K221908?
The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.