Cleared Traditional

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

K191334 · Matia Robotics (Us), Inc. · Physical Medicine device
May 2020
Decision
378d
Days
Class 2
Risk

K191334 is an FDA 510(k) clearance for the Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08. This device is classified as a Wheelchair, Standup (Class II - Special Controls, product code IPL).

Submitted by Matia Robotics (Us), Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 29, 2020, 378 days after receiving the submission on May 17, 2019.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3900.

Submission Details

510(k) Number K191334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2019
Decision Date May 29, 2020
Days to Decision 378 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code IPL - Wheelchair, Standup
Device Class Class II - Special Controls
CFR Regulation 21 CFR 890.3900