(45 days)
Not Found
No
The device description and performance studies focus on basic powered mobility and electrical safety, with no mention of AI or ML features.
No
The device is described as a mobility aid, specifically a powered scooter, which provides mobility to persons restricted to a seated position. It does not treat or cure any medical condition.
No
The device description states it is a "Powered Scooter" intended to "provide mobility to persons restricted to a seated position," which indicates it is a mobility aid, not a diagnostic device.
No
The device description clearly states it is a "Powered Scooter" with physical components like wheels, a seat, hand controls, and a battery. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing mobility to persons restricted to a seated position. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The description details a powered scooter for mobility, not equipment used to analyze biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or diagnostic procedures.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's purpose is entirely focused on physical assistance and mobility.
N/A
Intended Use / Indications for Use
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Product codes (comma separated list FDA assigned to the subject device)
INI
Device Description
The KARMA Scooter KS747.2 is an indoor / outdoor Powered Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the Scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
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)
EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Powered Scooters, controller, and their chargers requirements and test methods)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
WELL SUCCESS A&I Scooter, SC-402 (K041193)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the text "AUG - 5 2004" on the top left corner. To the right of the date is the logo for Karma home & health care. The logo includes the word "KARMA" in bold, black letters, with the words "home & health care" in a smaller font below. There is also a heart with a wing above the letter "M" in Karma.
KARMA MEDICAL 康揚股份有限公司 Tel:886-(0)5-2066688 Fax:886-(0)5-2067788
Http://www.KarmaMedical.com E-mail:eukarma@ms29.hinet.net
510(k) SUMMARY " દ્ધ
Submitter's Name: KARMA Medical Products Co., Ltd.
No. 2363, Sec.2, Da-Shiue Road, Min-Hsiung Shiang, Chia-Yi Hsien, 621, Taiwan, R.O.C.
June 14, 2004
Date summary prepared:
Device Name:
Proprietary Name:
KARMA Scooter, KS747.2
Common or Usual Name: Classification Name:
Electrical Scooter Motorized 4-Wheeled Vehicle, Class II, 21 CFR 890.3800
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Description of the device:
The KARMA Scooter KS747.2 is an indoor / outdoor Powered Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the Scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
Performance Testing:
EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Powered Scooters, controller, and their chargers requirements and test methods)
1
Image /page/1/Picture/0 description: The image shows the logo for Karma Home & Health Care. The word "Karma" is written in a bold, serif font. A heart shape with a swirl inside replaces the letter "A" in "Karma". A wing-like design is attached to the upper right side of the heart. Below "Karma" is the phrase "home & health care" in a smaller, sans-serif font.
KARMA MEDICAL PRODUCTS CO., LTD. 康揚 揚 股 份 有 限 公 司 U.K. U.S.A. TAIWAN THAI. Tel:886-1015-2066688 Fax:886-1015-2067788 Http://www.KarmaMedical.com E-mail:eukarma@ms29.hinet.net
Legally marketed device for substantial equivalence comparison: WELL SUCCESS A&I Scooter, SC-402 (K041193)
Summary for substantial equivalence comparison:
The intended uses, the size of tires, back upholstery, and warranty period between the new device KS747.2 and the predicate device SC-402 are all the same. Especially the electronic systems between two devices are the same suppliers and all passed by the UL certificated including the batteries, recharge, and the electronic controllers. Besides, the two devices are the same foldable frame, maximum speed, removable arm type, same warranty on component and frame, and back upholstery are the same material that also be passed the resistance ignition test by SGS. The major differences existing of the two Powered Scooters are the different overall dimension and weight between the two devices. The overall appearance and weight differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three wavy lines emanating from its head, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG = 5 2004
KARMA Medical Products Co., Ltd. C/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300
Re: K041677
Trade/Device Name: KARMA Scooter, KS-747.2 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: June 14, 2004 Received: June 21, 2004
Dear Dr. Jen:
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.
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.
3
Page 2 - Dr. Ke-Min Jen
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 marketed predicate device 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 contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Sincerely, yours,
Mark A. Mcllhennon
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page__________________________________________________________________________________________________________________________________________________________________________
510 (K) NUMBER ( IF KNOW ): _ TBA
DEVICE NAME: KARMA Scooter, KS-747.2
INDICATIONS FOR USE:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Prescription Use
AND/OR
Over-The-Counter Use √
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Afcurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
510(k) Number