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FDA 510(k)

Flexitouch® Plus Advanced Pneumatic Compression System

K-Number: K253555 · 2026-07-31

ApplicantTactile Medical
Decision Date2026-07-31
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Flexitouch® Plus Advanced Pneumatic Compression System is the device name listed in this FDA 510(k) record. The listed applicant is Tactile Medical. It received FDA 510(k) clearance on 2026-07-31 under 510(k) number K253555. 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 Advanced Pneumatic Compression System?

Flexitouch® Plus Advanced Pneumatic Compression System is a medical device that received FDA 510(k) clearance on 2026-07-31. The listed applicant is Tactile Medical. The 510(k) number is K253555.

When did Flexitouch® Plus Advanced Pneumatic Compression System receive FDA 510(k) clearance?

Flexitouch® Plus Advanced Pneumatic Compression System received FDA 510(k) clearance on 2026-07-31, under 510(k) number K253555.

Who is the listed applicant for Flexitouch® Plus Advanced Pneumatic Compression System?

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

What is the FDA product code for Flexitouch® Plus Advanced Pneumatic Compression System?

The FDA product code for Flexitouch® Plus Advanced Pneumatic Compression 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.

NCT07613931Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema TreatmentRECRUITINGNCT07603531Assessment of the Efficacy of the Dynamic Decongestive System in the Maintenance Phase of Lower Limb LymphedemaNOT_YET_RECRUITING

Other records listing 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.

K252849AffloVest® Mobile Airway Clearance TherapyK234155Nimbl (model PD08-N1)

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.

K253386DVT 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.,LtdK251466VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential ComprWellell, Inc.

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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