FDA 510(k) Premarket Notification K170216: Flexitouch System

Submission Details & Decision

Normalized public record details for 510(k) notification K170216.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K170216

Applicant / Sponsor

Tactile Systems Technology, Inc. (Dba Tactile Medical)

Device Name

Flexitouch System

Product Code

JOW

Decision Date

2017-05-26

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

2017-01-24

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