TEH LIN JUPITER POWER CHAIR, MODEL TL-320

• K Number: K022697
• Device Name: TEH LIN JUPITER POWER CHAIR, MODEL TL-320
• Manufacturer: TEH LIN PROSTHETIC & ORTHOPAEDIC, INC.
• Date Cleared: 2003-01-24 ( 164 days)
• Product Code: ITI
• Regulation Number: 890.3860
• Type: Traditional
• Panel: Physical Medicine
• Reference & Predicate Devices: N/A
• Predicate For: K042748 , K042749 , K050010 , K061693

Intended Use

The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Device Description

Not Found

AI/ML Overview

The provided text is a letter from the FDA regarding a 510(k) premarket notification for a powered wheelchair. It does not contain information about acceptance criteria or a study proving the device meets those criteria. My analysis indicates that the letter confirms the device (Teh Lin Jupiter Power Chair, TL-320) is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. The letter is a regulatory approval, not a technical report detailing performance testing.

Therefore, I cannot provide the requested information. The document does not contain details about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. A multi-reader multi-case (MRMC) comparative effectiveness study.
6. A standalone (algorithm only) performance study.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines suggesting hair or movement. The overall design is simple and conveys a sense of unity and service.

JAN 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Teh Lin Prosthetic & Orthopaedic, Inc. C/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58. Fu-Chiun St. Hsin Chu City, Taiwan, R.O.C.

Re: K022697

Trade/Device Name: Teh Lin Jupiter Power Chair, TL-320 Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: November 26, 2002 Received: December 2, 2002

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark N Milliman

Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page__________________________________________________________________________________________________________________________________________________________________________

510 (K) NUMBER ( IF KNOW ):__TBA DEVICE NAME: TEH LIN JUPITER POWER CHAIR, TL-320

INDICATIONS FOR USE:

The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. _

( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ( ANOTHER PAGE )

Concurrence of CDRH, office of Device Evaluation (ODE )

Prescription Use	OR	Over-The-Counter-Use
------------------	----	----------------------

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

for

(Division Sign-Off)

Division of General Restorative

and Neurological Devices

510(k) Number	K022697
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Regulation Number and Section

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).