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)

Vonflex S

K-Number: K152615 · 2016-11-03

Decision Date2016-11-03
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Vonflex S is the device name listed in this FDA 510(k) record. The listed applicant is Vericom Co., Ltd.. It received FDA 510(k) clearance on 2016-11-03 under 510(k) number K152615. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vonflex S?

Vonflex S is a medical device that received FDA 510(k) clearance on 2016-11-03. The listed applicant is Vericom Co., Ltd.. The 510(k) number is K152615.

When did Vonflex S receive FDA 510(k) clearance?

Vonflex S received FDA 510(k) clearance on 2016-11-03, under 510(k) number K152615.

Who is the listed applicant for Vonflex S?

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

What is the FDA product code for Vonflex S?

The FDA product code for Vonflex S is ELW.

Other records listing Vericom Co., Ltd. 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.

View all 8 devices →

Related Devices (Code: ELW)

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.