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)

FISIOWARM 7.0

K-Number: K232966 · 2024-12-26

ApplicantGolden Star Srl
Decision Date2024-12-26
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FISIOWARM 7.0 is the device name listed in this FDA 510(k) record. The listed applicant is Golden Star Srl. It received FDA 510(k) clearance on 2024-12-26 under 510(k) number K232966. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FISIOWARM 7.0?

FISIOWARM 7.0 is a medical device that received FDA 510(k) clearance on 2024-12-26. The listed applicant is Golden Star Srl. The 510(k) number is K232966.

When did FISIOWARM 7.0 receive FDA 510(k) clearance?

FISIOWARM 7.0 received FDA 510(k) clearance on 2024-12-26, under 510(k) number K232966.

Who is the listed applicant for FISIOWARM 7.0?

The FDA 510(k) record lists Golden Star Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FISIOWARM 7.0?

The FDA product code for FISIOWARM 7.0 is PBX.

Related Devices (Code: PBX)

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.

K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.K260647SPECCHIOEl.En S.P.A.K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.K252888NeoSculpt PlusS&M Medical Co., Ltd.K250734OptiLUV DevicePollogen, Ltd.K250916WinForth (LM-E470KA)Shenzhen Leaflife Technology Co., Ltd.

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.

↑