FDA 510(k)

Luftkompressions-Therapie-System FO-3001; Luftkompressions-Therapie-System FO-3008

K-Nummer: K201982 · 2021-03-25

Entscheidungsdatum2021-03-25

ProduktcodeIRP

BeratungsausschussPM

EntscheidungSubstantially Equivalent

Produktübersicht

Air compression therapy system FO-3001; Air compression therapy system FO-3008 is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Hongfeng Co., Ltd.. It received FDA 510(k) clearance on 2021-03-25 under 510(k) number K201982. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Air compression therapy system FO-3001; Air compression therapy system FO-3008?

Air compression therapy system FO-3001; Air compression therapy system FO-3008 is a medical device that received FDA 510(k) clearance on 2021-03-25. The listed applicant is Foshan Hongfeng Co., Ltd.. The 510(k) number is K201982.

When did Air compression therapy system FO-3001; Air compression therapy system FO-3008 receive FDA 510(k) clearance?

Air compression therapy system FO-3001; Air compression therapy system FO-3008 received FDA 510(k) clearance on 2021-03-25, under 510(k) number K201982.

Who is the listed applicant for Air compression therapy system FO-3001; Air compression therapy system FO-3008?

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

What is the FDA product code for Air compression therapy system FO-3001; Air compression therapy system FO-3008?

The FDA product code for Air compression therapy system FO-3001; Air compression therapy system FO-3008 is IRP.

Zugehörige klinische Studien

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Weitere Einträge mit Foshan Hongfeng Co., Ltd. als Antragsteller

K212169Luftkompressions-Therapie-System FO3002

Verwandte Geräte (Code: IRP)

K260944ManaCold Compression SystemManamed, LLC K260529Air Compression Massager (HY-1165)Xiamen High Top Electronic Technology Co., Ltd.K260948Air Compression Massager (EP30B001 I)Wavepulse (Xiamen) Healthcare Technology Co., Ltd.K253919Cryo And Thermo Therapy SystemXiamen Weiyou Intelligent Technology Co., Ltd.K252396Cryo Sport 2.0 (AVA 501)Avanutri Equipamentos DE Saúde K254200Luftkompressionsbeinmassager (Modell: LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14)Wenzhou Lingfeng Electronic Technology Co., Ltd.

Offizielle Quelle

In der FDA-Datenbank anzeigen →

Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.