Titan

K150086 · Tzora Active Systems , Ltd. · INI · Aug 5, 2015 · Physical Medicine

Device Facts

• Record ID: K150086
• Device Name: Titan
• Applicant: Tzora Active Systems , Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: Aug 5, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Indications for Use

The Titan 4W is a mobility assistive device for indoor use on mild terrain. It is not used as a transportation vehicle on roads and freeways used by cars.

Device Story

Titan 4W is an electrically powered, foldable, and disassemblable mobility scooter. Operated by the user via manual steering controls; intended for indoor and mild outdoor terrain. Provides motorized transport for individuals with mobility limitations. Features include lights and reflectors for low-visibility conditions. Device design facilitates portability and storage through folding and disassembly. User must possess sufficient physical strength for independent operation.

Clinical Evidence

No clinical data. Evidence consists of bench testing and a usability study. Bench testing included electromagnetic compatibility (IEC 60601-1-2) and comprehensive ISO 7176 wheelchair performance standards (Parts 1-6, 8-11, 13-16, 21). A usability study was conducted to validate system operation by the intended user population.

Technological Characteristics

Electrically powered, foldable, and disassemblable motorized scooter. Includes lights and reflectors. Complies with ISO 7176 series (wheelchair performance) and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for individuals with mobility limitations who retain sufficient arm and leg strength to independently mount/dismount and safely steer the device.

Regulatory Classification

Identification

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.

Predicate Devices

• Elite (K052204)

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

August 5, 2015

Tzora Active Systems, LTD. % Moshe Rosenberg Regulatory Consultant A. Stein- Regulatory Affairs Consulting Ltd. 20 Hata'as St. (PO Box 124), Kfar Saba, 4442520 Israel

K150086 Re: Trade/Device Name: Titan 4W Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: April 26, 2015 Received: July 6, 2015

Dear Moshe Rosenberg.

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.

Carlos L. Pena न्‍ज़/Δ

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) K150086

Device Name Titan 4W

Indications for Use (Describe)

The Titan 4W is a mobility assistive device for indoor use on mild terrain. It is not used as a transportation vehicle on roads and freeways used by cars.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) SUMMARY

## K150086 (Premarket Notification [510(k)] Number)

#### 1. Submitter Information

| Manufacturer Name and Address |
|-----------------------------------------------|
| Tzora Active Systems Ltd. |
| Kibbutz Tzora, |
| 9980300, |
| Israel |
| Official Correspondent |
| Ahava Stein |
| A. Stein - Regulatory Affairs Consulting Ltd. |
| 20 Hata'as St. (Beit Hapaamon, Suite 102) |
| Kfar Saba 4442520, |
| Israel |

Date Prepared: August 5, 2015 2.

- 3. Device Name Titan 4W

| Proprietary Name: | Titan 4W |
|-----------------------------|-----------------------------------------------|
| Common Name: | Vehicle, Motorized 3-Wheeled |
| FDA Classification<br>Name: | 21 CFR 890.3800; Vehicle, Motorized 3-Wheeled |

- FDA Classification: Class II, Product Code INI
#### 4. Predicate Devices

The Titan 4W is substantially equivalent to the following device:

| Manufacturer | Device | 510(k) | Date Cleared |
|---------------------------|--------|---------|-------------------|
| Tzora Active Systems Ltd. | Elite | K052204 | February 15, 2006 |

#### 5. Device Description

The Titan 4W scooter is an electrically powered scooter. It is intended to be used by individuals that are able to walk, but suffer from mobility limitations. The user must have sufficient arm and leg strength to get on and off the Titan 4W alone and to safely steer under all driving conditions.

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The Titan 4W is intended for indoor use and outdoor use. The Titan 4W has reflectors and lights, which should be used in the dark or in limited visibility conditions.

The Titan 4W can be folded and disassembled into two parts. This allows for easy storage and enables portability of the Titan 4W.

#### 6. Indications for Use

The Titan 4W is a mobility assistive device for indoor use on mild terrain. It is not used as a transportation vehicle on roads and freeways used by cars.

#### 7. Performance Standards

There are no performance standards under the Federal Food, Drug and Cosmetic Act, for the Titan 4W.

#### Performance Testing 8.

The following performance, safety and usability tests were conducted with the Titan 4W:

- IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General requirements for . basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (2007)
- ISO 7176 Wheelchairs -- Parts 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 13, 14, 15, 16, and 21. .
- Usability Study validated the system's usability by the intended user. .

#### 9. Technological Characteristics Compared to Predicate Device

The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the indications for use of the Titan 4W are substantially equivalent to the predicate device cited above.