Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Hanuri Distribution, Inc.. It received FDA 510(k) clearance on 2020-10-21 under approval 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. It is manufactured by Hanuri Distribution, Inc.. The 510(k) number is K202044.

When was Powerpress Recovery Unit approved by the FDA?

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

What company makes Powerpress Recovery Unit?

Powerpress Recovery Unit is manufactured by Hanuri Distribution, Inc..

What is the FDA product code for Powerpress Recovery Unit?

The FDA product code for Powerpress Recovery Unit is IRP.

Related Devices (Code: IRP)

K160608NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP K171685Med4 EliteCool Systems, Inc. (Dba Game Ready) K161907Pressure Therapy SystemXiamen Senyang Co., Ltd. K163280RP Lite 760RMego Afek AC , Ltd. K160178Lympha-Flow(LF1200)Daesung Maref Co., Ltd. K183169Pulse 2.0, Pulse Pro 2.0NormaTec Industries, LP

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.

↑