Tek RMD (Tek Robotic Mobilization Device)

K150548 · Matia Robotics Mekatroik Sis. Ar-Ge Muh. Yaz.San VE Tic.A.S · IPL · Jun 11, 2015 · Physical Medicine

Device Facts

• Record ID: K150548
• Device Name: Tek RMD (Tek Robotic Mobilization Device)
• Applicant: Matia Robotics Mekatroik Sis. Ar-Ge Muh. Yaz.San VE Tic.A.S
• Product Code: IPL · Physical Medicine
• Decision Date: Jun 11, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3900
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

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 Story

Tek RMD is an electric lift and mobile stander; enables users to transition from seated to passive standing position. Device operates as a mobility aid for individuals with limited lower limb function. User-operated via integrated controls. Provides postural change to standing, facilitating mobility and potential physiological benefits associated with upright positioning. Used in home or clinical environments.

Technological Characteristics

Electric lift and mobile stander; powered by electric motor; provides passive standing support. Class II device (21 CFR 890.3900).

Indications for Use

Indicated for individuals requiring assistance to transition from a seated to a passive standing position. Prescription use only.

Regulatory Classification

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.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 11, 2015

Matia Robotics Mekatroik Sistemler Ar-ge Muh. Yaz. San. ve Tic A.S c/o Dave Yungvirt CEO Third Party Review Group, LLC 45 Rockefeller Plaza Suite 2000 New York, New York 10111

Re: K150548

Trade/Device Name: Tek RMD (Robotic Mobilization Device) Regulation Number: 21 CFR 890.3900 Regulation Name: Standup Wheelchair Regulatory Class: Class II Product Code: IPL Dated: May 26, 2015 Received: May 29, 2015

Dear Mr. Yungvirt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Felipe Aquel -S

for

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K150548

Device Name Tek RMD (Robotic Mobilization Device)

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable):

| <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Remediation Use (Part 31, GER 901.3 and Part </span> |
|-------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <input type="checkbox"/> On-Site Corrective Action (31 GER 901.3 and </span> |

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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