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FDA 510(k)

Air Pressure Foot Massager

K-Number: K212935 · 2022-02-19

ApplicantXiamen Simo Electronic Co., Ltd.
Decision Date2022-02-19
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Air Pressure Foot Massager is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen Simo Electronic Co., Ltd.. It received FDA 510(k) clearance on 2022-02-19 under 510(k) number K212935. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Air Pressure Foot Massager?

Air Pressure Foot Massager is a medical device that received FDA 510(k) clearance on 2022-02-19. The listed applicant is Xiamen Simo Electronic Co., Ltd.. The 510(k) number is K212935.

When did Air Pressure Foot Massager receive FDA 510(k) clearance?

Air Pressure Foot Massager received FDA 510(k) clearance on 2022-02-19, under 510(k) number K212935.

Who is the listed applicant for Air Pressure Foot Massager?

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

What is the FDA product code for Air Pressure Foot Massager?

The FDA product code for Air Pressure Foot Massager is IRP.

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_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Related Devices (Code: IRP)

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.

K260944ManaCold Compression SystemManamed, LLCK260529Air 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 SaúdeK254200Air Compression Leg Massager (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.

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.

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