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K Number
K191334
Device Name
Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08
Manufacturer
MATIA Robotics (US) Inc
Date Cleared
2020-05-29

(378 days)

Product Code
IPL
Regulation Number
890.3900
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Tek RMD (Robotic Mobilization Device) is an electric lift and mobile stander and brings the user from a seated position to a passive standing position.

Device Description

Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) Models: TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD06, TEKRMD06, TEKRMD07, TEKRMD08

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding the Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE). This document does not contain any information about acceptance criteria, device performance, clinical study design, or ground truth establishment relevant to an AI/ML medical device.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval, product codes, and general controls, rather than a performance evaluation of the device based on specific criteria.

§ 890.3900 Standup wheelchair.

(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).