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Data / Medical devices / United States / CC Wellness LLC

CC Wellness LLC: FDA-registered device maker in Valencia, CA, United States, 27 510(k) clearances

CC Wellness LLC is registered with the FDA (registration 3013395518) in Valencia, CA, United States. It lists 4 device types. The FDA files 27 510(k) clearances under its listings, the newest dated October 22, 2023. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch CC Wellness LLC
FDA registration number
3013395518
Address
24903 Avenue Kearny, Valencia, CA, United States, 91355
Owner or operator
CC Wellness, LLC. (10049988)
Roles
Contract manufacturer, Manufacturer
First device listed
September 25, 2015
Registered through
2027
Brand names listed
#LubeLife - Cum Lubricant - 8oz / 240 ml (40834), #LubeLife - Peaches & Cream - 8oz / 240mL (40842), #LubeLife - Strawberry Foil 10mL (79046-IH), #LubeLife - Water-Based Gel Lubricant - 4 floz / 120 mL (40798), #LubeLife - Water-based - 4oz / 120ml - International (40796-INT), #LubeLife - Water-based Anal 2oz - 3pk (20604), #LubeLife - Watermelon 8oz (40781), #LubeLife - Watermelon Foil 10mL (79038-IH) and more

Devices it lists

DeviceProduct codeClassRoleSource
CondomHIS2Contract manufactureraccessdata.fda.gov
Enema KitFCE1Manufactureraccessdata.fda.gov
Lubricant, PersonalNUC2Contract manufacturer, Manufactureraccessdata.fda.gov
Lubricant, Personal, Gamete, Fertilization, And Embryo CompatiblePEB2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 22, 2023K232091JO Coconut Hybrid Cooling Personal LubricantNUCSubstantially EquivalentCC Wellness, LLCaccessdata.fda.gov
October 11, 2023K232090JO Coconut Hybrid Warming Personal LubricantNUCSubstantially EquivalentCC Wellness, LLCaccessdata.fda.gov
May 8, 2023K230674JO 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 40114NUCSubstantially EquivalentCC Wellness, LLCaccessdata.fda.gov
September 20, 2022K221908JO CUMPLAY Personal LubricantNUCSubstantially EquivalentCC Wellness, LLCaccessdata.fda.gov
February 11, 2022K212885Actively Trying Personal Lubricant Rose ScentedPEBSubstantially EquivalentCC Wellness, LLCaccessdata.fda.gov
February 9, 2022K212705Actively Trying Personal Lubricant UnfragrancePEBSubstantially EquivalentCC Wellness, LLCaccessdata.fda.gov
June 10, 2021K210986H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure KitNUCSubstantially EquivalentCC Wellness, LLCaccessdata.fda.gov
June 10, 2021K210972H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit for TwoNUCSubstantially EquivalentCC Wellness, LLCaccessdata.fda.gov
July 2, 2020K200894Agape Cooling Personal LubricantNUCSubstantially EquivalentCC Wellness, LLCaccessdata.fda.gov
June 3, 2020K200602Premium Cooling Personal Lubricant, Premium Anal Cooling LubricantNUCSubstantially EquivalentCC Wellness, LLCaccessdata.fda.gov
May 22, 2020K200457Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One WarmingNUCSubstantially EquivalentCC Wellness, LLCaccessdata.fda.gov
April 27, 2020K200208Agape Warming Personal LubricantNUCSubstantially EquivalentCC Wellness, LLCaccessdata.fda.gov
February 10, 2020K192203JO for Him H2O Gel Original Personal LubricantNUCSubstantially EquivalentUnited Consortiumaccessdata.fda.gov
September 18, 2019K190858Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal LubricantNUCSubstantially EquivalentUnited Consortiumaccessdata.fda.gov
August 1, 2019K191214JO Premium Jelly Original Personal LubricantNUCSubstantially EquivalentUnited Consortiumaccessdata.fda.gov
April 26, 2019K182585JO Actively Trying Personal LubricantPEBSubstantially EquivalentUnited Consortiumaccessdata.fda.gov
April 17, 2019K183584JO H2O Jelly Original Personal LubricantNUCSubstantially EquivalentUnited Consortiumaccessdata.fda.gov
March 4, 2019K183384JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal LubricantNUCSubstantially EquivalentUnited Consortiumaccessdata.fda.gov
November 14, 2018K182105JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal LubricantNUCSubstantially EquivalentUnited Consortiumaccessdata.fda.gov
August 27, 2018K181408JO Classic Hybrid Personal LubricantNUCSubstantially EquivalentUnited Consortiumaccessdata.fda.gov
June 6, 2018K180712Coconut Infused Hybrid Personal LubricantNUCSubstantially EquivalentUnited Consortiumaccessdata.fda.gov
April 20, 2018K180219JO H2O Flavored Personal LubricantsNUCSubstantially EquivalentUnited Consortiumaccessdata.fda.gov
April 9, 2018K180083Silicone Personal Lubricant, ALL-IN-ONENUCSubstantially EquivalentUnited Consortiumaccessdata.fda.gov
October 31, 2017K172447JO Gelato Flavored Personal LubricantsNUCSubstantially EquivalentUnited Consortiumaccessdata.fda.gov
July 18, 2017K171021JO Agapé Personal LubricantNUCSubstantially EquivalentUnited Consortiumaccessdata.fda.gov
July 8, 2015K150480JO H20 Water Based Personal LubricantNUCSubstantially EquivalentUnited Consortium, Inc.accessdata.fda.gov
June 11, 2014K132954JO PREMIUM PERSONAL LUBRICANTNUCSubstantially EquivalentUnited Consortiumaccessdata.fda.gov

Compare with other makers

Updated October 22, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.