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FDA 510(k)

ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM

K-Number: K131193 · 2013-06-18

ApplicantTactile Systems Technology, Inc.
Decision Date2013-06-18
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY 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 2013-06-18 under 510(k) number K131193. 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 ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM?

ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2013-06-18. The listed applicant is Tactile Systems Technology, Inc.. The 510(k) number is K131193.

When did ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM receive FDA 510(k) clearance?

ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM received FDA 510(k) clearance on 2013-06-18, under 510(k) number K131193.

Who is the listed applicant for ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY 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 ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM?

The FDA product code for ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY 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.

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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.

K120972FLEXITOUCH SYSTEMK062818FLEXITOUCH 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

View on FDA Database →

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

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