H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Ta…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K210972 FDA 510(k)
- FDA Product Code
- NUC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.5300 FDA 510(k)
- Regulation Number
- 884.5300 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
H2O Warming Personal Lubricant is a water-based personal lubricant designed to supplement the body's natural lubrication. It provides a silky smooth and comforting glide with no stick or tack residue. The formula is toy friendly, condom compatible, and easy to clean.
The device is supplied in various forms including H2O Anal Warming Personal Lubricant and JO 2 To Tango Couples Pleasure Kit. It is regulated as a Class II device with FDA 510(k) clearance under product code NUC. The device is manufactured by CC Wellness LLC and is intended for personal lubrication purposes.
Frequently asked questions
What is H2O Warming Personal Lubricant used for?
H2O Warming Personal Lubricant is designed to supplement the body's natural lubrication, providing a silky smooth and comforting glide with no stick or tack residue. It is intended for personal lubrication purposes.
How is the H2O Warming Personal Lubricant supplied?
The device is supplied in various forms including H2O Anal Warming Personal Lubricant and JO 2 To Tango Couples Pleasure Kit. Each form maintains the same water-based formula that provides a silky smooth glide.
Is the H2O Warming Personal Lubricant compatible with condoms and sex toys?
Yes, the formula is toy friendly and condom compatible, making it suitable for use with various personal products. It is also easy to clean, which adds to its convenience for users.
What is the regulatory status of the H2O Warming Personal Lubricant?
The device is regulated as a Class II device with FDA 510(k) clearance under product code NUC. It was manufactured by CC Wellness LLC and received clearance on June 10, 2021.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: JO H2O Lubricant - Warming ( 2 oz ) - amazon.com, H2O Anal Warming Lubricant - ShopJo.com, JO H2O Water Based Lube, Warming Personal Lubricant for ... - Amazon
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210972 | Class II | Active |
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Manufacturer
- Manufacturer
- CC Wellness LLC
- FDA Applicant
- CC Wellness, LLC
Sources (1)
- FDA 510(k) K210972 24 fields · synced Oct 6, 2026