Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08— 510(k) K191334

Name: FDA 510(k) clearance K191334
Creator: U.S. Food and Drug Administration
Published: 2020-05-29

Substantially Equivalent

Matia Robotics (Us), Inc.

FDA 510(k) clearance K191334 for Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08, Substantially Equivalent on 2020-05-29. Applicant: Matia Robotics (Us), Inc.. Device class: 2.

Clearance details

Applicant: Matia Robotics (Us), Inc.
Product code: Code IPL
Device class: Class 2
Regulation: 21 CFR 890.3900
Advisory panel: Physical Medicine
Date received: 2019-05-17
Decision date: 2020-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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