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FDA 510(k)

Powerpress Recovery Unit

K-Number: K202044 · 2020-10-21

ApplicantHanuri Distribution, Inc.
Decision Date2020-10-21
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Powerpress Recovery Unit is the device name listed in this FDA 510(k) record. The listed applicant is Hanuri Distribution, Inc.. It received FDA 510(k) clearance on 2020-10-21 under 510(k) number K202044. 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 Powerpress Recovery Unit?

Powerpress Recovery Unit is a medical device that received FDA 510(k) clearance on 2020-10-21. The listed applicant is Hanuri Distribution, Inc.. The 510(k) number is K202044.

When did Powerpress Recovery Unit receive FDA 510(k) clearance?

Powerpress Recovery Unit received FDA 510(k) clearance on 2020-10-21, under 510(k) number K202044.

Who is the listed applicant for Powerpress Recovery Unit?

The FDA 510(k) record lists Hanuri Distribution, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powerpress Recovery Unit?

The FDA product code for Powerpress Recovery Unit 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

Other records listing Hanuri Distribution, Inc. 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.

K110276POWERPRESS UNIT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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