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)

ELECTROTHERAPY DEVICE (COMBO UNIT)

K-Number: K130691 · 2013-12-20

ApplicantGuangzhou Finecure Medical Equipment Co.,Ltd
Decision Date2013-12-20
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ELECTROTHERAPY DEVICE (COMBO UNIT) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Finecure Medical Equipment Co.,Ltd. It received FDA 510(k) clearance on 2013-12-20 under 510(k) number K130691. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTROTHERAPY DEVICE (COMBO UNIT)?

ELECTROTHERAPY DEVICE (COMBO UNIT) is a medical device that received FDA 510(k) clearance on 2013-12-20. The listed applicant is Guangzhou Finecure Medical Equipment Co.,Ltd. The 510(k) number is K130691.

When did ELECTROTHERAPY DEVICE (COMBO UNIT) receive FDA 510(k) clearance?

ELECTROTHERAPY DEVICE (COMBO UNIT) received FDA 510(k) clearance on 2013-12-20, under 510(k) number K130691.

Who is the listed applicant for ELECTROTHERAPY DEVICE (COMBO UNIT)?

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

What is the FDA product code for ELECTROTHERAPY DEVICE (COMBO UNIT)?

The FDA product code for ELECTROTHERAPY DEVICE (COMBO UNIT) is IPF.

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

Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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.

↑