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FDA 510(k)

Reprocessed Tri Pulse Compression Garment

K-Number: K203847 · 2021-05-07

ApplicantRenu Medical, Inc.
Decision Date2021-05-07
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Tri Pulse Compression Garment is the device name listed in this FDA 510(k) record. The listed applicant is Renu Medical, Inc.. It received FDA 510(k) clearance on 2021-05-07 under 510(k) number K203847. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed Tri Pulse Compression Garment?

Reprocessed Tri Pulse Compression Garment is a medical device that received FDA 510(k) clearance on 2021-05-07. The listed applicant is Renu Medical, Inc.. The 510(k) number is K203847.

When did Reprocessed Tri Pulse Compression Garment receive FDA 510(k) clearance?

Reprocessed Tri Pulse Compression Garment received FDA 510(k) clearance on 2021-05-07, under 510(k) number K203847.

Who is the listed applicant for Reprocessed Tri Pulse Compression Garment?

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

What is the FDA product code for Reprocessed Tri Pulse Compression Garment?

The FDA product code for Reprocessed Tri Pulse Compression Garment is JOW.

Related Devices (Code: JOW)

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.

K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.K250974Bio Arterial Deluxe (IC-BAP-DX)Bio Compression Systems, Inc.K250190Sequential Compression System (SCD600)Shenzhen Comen Medical Instruments 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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