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FDA 510(k)

PERSONAL WARMING GEL

K-Number: K050211 · 2005-03-17

ApplicantQualis, Inc.
Decision Date2005-03-17
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PERSONAL WARMING GEL is the device name listed in this FDA 510(k) record. The listed applicant is Qualis, Inc.. It received FDA 510(k) clearance on 2005-03-17 under 510(k) number K050211. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERSONAL WARMING GEL?

PERSONAL WARMING GEL is a medical device that received FDA 510(k) clearance on 2005-03-17. The listed applicant is Qualis, Inc.. The 510(k) number is K050211.

When did PERSONAL WARMING GEL receive FDA 510(k) clearance?

PERSONAL WARMING GEL received FDA 510(k) clearance on 2005-03-17, under 510(k) number K050211.

Who is the listed applicant for PERSONAL WARMING GEL?

The FDA 510(k) record lists Qualis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERSONAL WARMING GEL?

The FDA product code for PERSONAL WARMING GEL is NUC.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Qualis, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K050212PERSONAL WARMING JELLYK041129PERSONAL LUBRICATING GELK040085PERSONAL WARMING LUBRICANTK973780PERSONAL LUBRICATING LIQUIDK973557LUBRIGLIDE

Related Devices (Code: NUC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260117EverslideSpecial Situations, LLCK253989HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST)Maxigen Biotech, Inc.K261905BUM OilBumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPINKSLIP, LLCK261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.K254011Flow Water-Based Personal LubricantLBDO Group, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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