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FDA 510(k)

Flexitouch Plus System

K-Number: K203178 · 2020-12-20

ApplicantTactile Systems Technology, Inc. (Dba Tactile Medical)
Decision Date2020-12-20
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Flexitouch Plus System is the device name listed in this FDA 510(k) record. The listed applicant is Tactile Systems Technology, Inc. (Dba Tactile Medical). It received FDA 510(k) clearance on 2020-12-20 under 510(k) number K203178. 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 Flexitouch Plus System?

Flexitouch Plus System is a medical device that received FDA 510(k) clearance on 2020-12-20. The listed applicant is Tactile Systems Technology, Inc. (Dba Tactile Medical). The 510(k) number is K203178.

When did Flexitouch Plus System receive FDA 510(k) clearance?

Flexitouch Plus System received FDA 510(k) clearance on 2020-12-20, under 510(k) number K203178.

Who is the listed applicant for Flexitouch Plus System?

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

What is the FDA product code for Flexitouch Plus System?

The FDA product code for Flexitouch Plus System is JOW.

Other records listing Tactile Systems Technology, Inc. (Dba Tactile Medical) 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.

K170216Flexitouch SystemK153311Flexitouch System

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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