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FDA 510(k)

FLEXITOUCH SYSTEM

K-Number: K062818 · 2006-10-06

ApplicantTactile Systems Technology, Inc.
Decision Date2006-10-06
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLEXITOUCH SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tactile Systems Technology, Inc.. It received FDA 510(k) clearance on 2006-10-06 under 510(k) number K062818. 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 SYSTEM?

FLEXITOUCH SYSTEM is a medical device that received FDA 510(k) clearance on 2006-10-06. The listed applicant is Tactile Systems Technology, Inc.. The 510(k) number is K062818.

When did FLEXITOUCH SYSTEM receive FDA 510(k) clearance?

FLEXITOUCH SYSTEM received FDA 510(k) clearance on 2006-10-06, under 510(k) number K062818.

Who is the listed applicant for FLEXITOUCH SYSTEM?

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

What is the FDA product code for FLEXITOUCH SYSTEM?

The FDA product code for FLEXITOUCH SYSTEM is JOW.

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_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Tactile Systems Technology, 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.

K131193ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEMK120972FLEXITOUCH SYSTEMK013061BIOTOUCH MASSAGE THERAPY 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.

K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)Bio Compression Systems, Inc.K254217AerloomEvolym, LLCK253555Flexitouch® 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.

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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