510(k) K221137
K221137 is an FDA 510(k) premarket notification submitted by Innovemed Bio-Tech Co., Ltd. for the device "Play and Joy Water-Based Lubricant". The FDA issued a decision of Substantially Equivalent on Jul 11, 2023. The device falls under product code NUC (Lubricant, Personal), a Class II device regulated under 21 CFR 884.5300. Innovemed Bio-Tech Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 11, 2023
- Date Received
- Apr 19, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lubricant, Personal
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type
- 510(k)
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.