Kudu

K151492 · R82 A/S · IOR · May 20, 2016 · Physical Medicine

Device Facts

• Record ID: K151492
• Device Name: Kudu
• Applicant: R82 A/S
• Product Code: IOR · Physical Medicine
• Decision Date: May 20, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended Use

The Kudu is a wheelchair intended purposes to provide mobility to children limited to a sitting position. It is designed for indoor and outdoor use over smooth surfaces.

Device Story

Kudu is a mechanical wheelchair designed to provide mobility for children who are limited to a sitting position. The device is intended for use in both indoor and outdoor environments, specifically on smooth surfaces. It functions as a manual mobility aid, allowing the user or a caregiver to navigate. The device is operated by the patient or an assistant to facilitate movement and improve patient independence. It does not involve electronic inputs, software, or automated processing.

Clinical Evidence

Bench testing only.

Technological Characteristics

Mechanical wheelchair; manual operation; designed for pediatric use; intended for indoor/outdoor use on smooth surfaces. No electronic components, software, or sensors.

Indications for Use

Indicated for children limited to a sitting position requiring mobility assistance for indoor and outdoor use on smooth surfaces.

Regulatory Classification

Identification

A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Submission Summary (Full Text)

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

May 20, 2016

R82 A/S Ulla Lange Director of Quality and Regulatory Affairs Parallelvej 3 Gedved, DK-8751 Denmark

Re: K151492 Trade/Device Name: Kudu Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR, LBE Dated: April 19, 2016 Received: April 20, 2016

Dear Ulla Lange:

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 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

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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 (QS) 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.

## Michael J. Hoffmann -A

- 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) K151492

Device Name Kudu

Indications for Use (Describe)

The Kudu is a wheelchair intended purposes to provide mobility to children limited to a sitting position. It is designed for indoor and outdoor use over smooth surfaces.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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