(100 days)
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.
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.
This FDA 510(k) clearance letter for the Tek RMD (Robotic Mobilization Device) does not contain specific details about acceptance criteria, device performance results, or a detailed study description as typically found in an AI/ML device submission summary.
The document is a clearance letter from the FDA to Matia Robotics, indicating that their device has been found substantially equivalent to a legally marketed predicate device. This type of document confirms regulatory clearance but does not delve into the granular technical details of performance evaluation for AI/ML devices.
Therefore, the requested information cannot be extracted from the provided text. To answer your questions, one would need to access the actual 510(k) submission summary for K15058, which would contain the performance study details.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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):
| Remediation Use (Part 31, GER 901.3 and Part |
|---|
| On-Site Corrective Action (31 GER 901.3 and |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 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).