Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Natureplex Warm Touch Warming Jelly

K-Number: K180828 · 2018-12-20

Decision Date2018-12-20
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Natureplex Warm Touch Warming Jelly is the device name listed in this FDA 510(k) record. The listed applicant is Natureplex, LLC. It received FDA 510(k) clearance on 2018-12-20 under 510(k) number K180828. 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 Natureplex Warm Touch Warming Jelly?

Natureplex Warm Touch Warming Jelly is a medical device that received FDA 510(k) clearance on 2018-12-20. The listed applicant is Natureplex, LLC. The 510(k) number is K180828.

When did Natureplex Warm Touch Warming Jelly receive FDA 510(k) clearance?

Natureplex Warm Touch Warming Jelly received FDA 510(k) clearance on 2018-12-20, under 510(k) number K180828.

Who is the listed applicant for Natureplex Warm Touch Warming Jelly?

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

What is the FDA product code for Natureplex Warm Touch Warming Jelly?

The FDA product code for Natureplex Warm Touch Warming Jelly is NUC.

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.

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.