(100 days)
THIS DEVICE IS A CHAIR WITH LARGE WHEELS WHICH ARE USED TO MOVE AND TURN THE CHAIR BY THE USER. IT CAN BE USED ON A FLAT SURFACE IN A ROOM, A YARD, OR PAVED SURFACE. IT IS ESPECIALLY USEFUL TO THOSE WHO ARE UNABLE TO WALK OR LACK USE OF THEIR LEGS, ALLOWING THE USER A DEGREE OF MOBILITY. THIS CHAIR DOES NOT HAVE A RECLINING FEATURE.
Mechanical (manual) wheelchair #KE-1M
The provided text describes a Premarket Notification 510(k) Summary for a "Mechanical (manual) wheelchair #KE-1M" by KENSTONE METAL CO., LTD. This document focuses on establishing substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data for a complex medical device with an AI component. Therefore, I cannot extract the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for training/test sets.
The document primarily provides administrative and regulatory details:
- Applicant: KENSTONE METAL CO., LTD.
- Device Name: Mechanical (manual) wheelchair #KE-1M
- Trade Name: Kenstone
- Classification: Class 1
- Equivalent Device: Graham Field Vista Model 31-52005510
- Intended Use: To aid mobility of persons having difficulty walking
- Technological characteristics: Function and design is same as equivalent device
- K Number: K990139
- FDA Decision Date: April 29, 1999
The FDA's letter states that the device is "substantially equivalent" to legally marketed devices, allowing it to proceed to market under general controls. This type of 510(k) submission generally relies on demonstrating that the new device has the same intended use, technological characteristics, and safety/effectiveness profile as a predicate device, often without requiring extensive clinical trials with pre-defined acceptance criteria and statistical performance measures as would be expected for novel or high-risk devices, especially those incorporating AI.
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4/29/99
provi
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KENSTONE METAL CO., LTD.
9, Road 5, Taichung Ind. Park, Taichung, Taiwan 407 Tel: (04) 359-3591 Fax: (04) 359-3589/90
PREMARKET NOTIFICATION 510(K) SUMMARY
As required by Section 807.92(c)
Date submitted: 1/4/99
Kenstone Metal (Kunshan) Co., Ltd. 22 Zhanjin East Rd., Peglang Town Kunshan City, Jiansu China
| Contact person: | James Yang |
|---|---|
| Telephone: | 86-520-761-2811 |
| Fax: | 86-520-761-2815 |
| Device Name: | Mechanical (manual) wheelchair #KE-1M |
| Trade Name: | Kenstone |
| Classification: | Class 1 |
| Equivalent device: | Graham Field Vista Model 31-52005510 |
| Intended use: | To aid mobility of persons having difficulty walking |
| Technological characteristics: | Function and design is same as equivalent device |
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three abstract human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 1999
Mr. Lonnie Wells Kenda USA 7095 Americana Parkway P.O. Box 0132 Reynoldsburg, Ohio 43068-4118
K990139 Re: Kenstone Trade Name: Regulatory Class: I Product Code: IOR March 10, 1999 Dated: Received: March 18, 1999
Dear Mr. Wells:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate able beated in 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Lonnie Wells
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other gener Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):_ K990139
. MECHANICAL (MANUAL) WHEELCHAIR Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
THIS DEVICE IS A CHAIR WITH LARGE WHEELS WHICH ARE USED TO MOVE AND TURN THE CHAIR BY THE USER. IT CAN BE USED ON A FLAT SURFACE IN A ROOM, A YARD, THIS CHAIR DOES NOT HAVE A RECLINING FEATURE. OR PAVED SURFACE. IT IS ESPECIALLY USEFUL TO THOSE WHO ARE UNABLE TO WALK OR LACK USE OF THEIR LEGS, ALLOWING THE USER A DEGREE OF MOBILITY.
Image /page/3/Picture/5 description: The image shows a black and white drawing of a round object. The object appears to be textured with many small dots covering its surface. The top left portion of the object is partially cut off, giving it a slightly incomplete appearance.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
.
(Division Sign-O Division of General Restorative 510(k) Number
Prescription Use Per 21 CFR 801.109) OR
Over-The-Counter Use X
(Optional Format 1-2-96)
§ 890.3850 Mechanical wheelchair.
(a)
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.(b)
Classification. Class I (general controls).