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)

Hydroven 12, Hydroven 12 Garments

K-Number: K152228 · 2016-04-04

Decision Date2016-04-04
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Hydroven 12, Hydroven 12 Garments is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Healthcare , Ltd.. It received FDA 510(k) clearance on 2016-04-04 under 510(k) number K152228. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hydroven 12, Hydroven 12 Garments?

Hydroven 12, Hydroven 12 Garments is a medical device that received FDA 510(k) clearance on 2016-04-04. The listed applicant is Huntleigh Healthcare , Ltd.. The 510(k) number is K152228.

When did Hydroven 12, Hydroven 12 Garments receive FDA 510(k) clearance?

Hydroven 12, Hydroven 12 Garments received FDA 510(k) clearance on 2016-04-04, under 510(k) number K152228.

Who is the listed applicant for Hydroven 12, Hydroven 12 Garments?

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

What is the FDA product code for Hydroven 12, Hydroven 12 Garments?

The FDA product code for Hydroven 12, Hydroven 12 Garments is JOW.

Other records listing Huntleigh Healthcare , 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 7 devices →

Related Devices (Code: JOW)

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.