(97 days)
No
The summary describes a standard electric scooter with manual controls and does not mention any AI or ML components or functionalities.
No
A therapeutic device is used to treat or alleviate a disease or condition. This device is a mobility scooter intended for transportation, not treatment.
No
The device is described as a scooter for transportation, not a tool for diagnosing medical conditions.
No
The device description clearly outlines a physical, battery-operated scooter with a tiller handle and throttle control, indicating it is a hardware device, not software-only.
No, the Ruike 3331 scooter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. This includes things like blood, urine, tissue, etc., to diagnose diseases or conditions.
- The Ruike 3331 scooter is a mobility device. Its intended use is to provide transportation for disabled or elderly persons. It does not interact with or analyze any biological specimens.
The provided information clearly describes a transportation vehicle, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Ruike 3331 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
The Ruike 3331 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
Product codes
89INI, INI
Device Description
The Ruike 3331 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
LANDLEX P100X (K060042)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3800 Motorized three-wheeled vehicle.
(a)
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.(b)
Classification. Class II (performance standards).
0
DEC 1 4 2006
Shanghai Ruike Sports Goods CO., LTD.
No. 689, Xinhu Road, Shanghai, China TEL: +86-21-66350714 FAX: +86-21-66351873
510(k) Summary
Device
Trade name: Ruike 3331 scooter
Common name: Electrical scooter
Classification name: Motorized three-wheeled vehicle
Medical specialty (Panel): Physical Medicine Device
Regulation number: 890.3800
Product Code: 89INI
Classification: Class II
Predicate devices
LANDLEX P100X (K060042)/ Besteam Technology Inc.
Intend use of device
Ruike 3331 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
Device description:
The Ruike 3331 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
Substantial equivalence:
The Ruike 3331 scooter is substantially equivalent to the LANDLEX P100X (K060042) manufactured by Besteam Technology Inc.
There are minor differences in performance specifications of the scooters, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness. Therefore, Shanghai Ruike Sports Goods CO., LTD. believes that the Ruike 3331 scooter is substantially equivalent to legally marketed devices currently in commercial distribution.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shanghai Ruike Sports Goods Co., Ltd. % Ms. Junnata Chang 14F-2, No. 1, Lane 25 Banqiao, Taipei County, China (Taiwan) 220
Re: K062676
Trade/Device Name: Ruike 3331 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: November 16, 2006 Received: November 16, 2006
Dear Ms. Chang:
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.
DEC 1 4 2006
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Part 807); labeling (21 CFR Part 801); 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.
2
Page 2 – Ms. Junnata Chang
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally prematics notification. "The results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice io. Jour accipital and please note the regulation entitled, Colliact the Office of Compuner as (21 the Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour response Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for
Mark N. Melkerson
Director
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
3. Device descriptive information
3.1 Statement of indication for use
Statement of Indications for Use
K062676 510(k) Number (if known): __
Device Name: Ruike 3331
Indications for Use:
The Ruike 3331 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
| Prescription Use | Over-The-Counter Use X | |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | AND/OR | (Part 21 CFR 807 Subpart C) |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER | ||
| PAGE OF NEEDED) | ||
| Concurrence of CDRH, Office of Device Evaluation (ODE) | Page 1 of 1 | |
| L062676 | ||
| (Division Sign-Off) | ||
| Division of General, Restorative, | ||
| and Neurological Devices | ||
| 510(k) Number | L062676 |
(Posted November 13, 2003)
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