(42 days)
Not Found
No
The description focuses on mechanical aspects and standard wheelchair features, with no mention of AI or ML.
No
Explanation: A therapeutic device is designed to treat, cure, or prevent disease, or to relieve symptoms. While a wheelchair provides mobility and can improve quality of life, it does not directly treat or cure any medical condition. It is a mobility aid rather than a therapeutic intervention.
No
The device is a mechanical wheelchair used for mobility, not for diagnosing medical conditions.
No
The device description clearly describes a physical, mechanical wheelchair with hardware components (base, wheels, seat, upholstery). There is no mention of software as the primary or sole component.
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 mechanical function for physical support and movement.
- Device Description: The description details a mechanical wheelchair with wheels, a seat, and a frame. There is no mention of components or functions related to testing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This wheelchair does not fit that description.
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)
IOR
Device Description
The MAXHEALTH Mechanical Wheelchair, K1 is indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.
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)
MAXHEALTH Mechanical Wheelchair, K1 meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.
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.
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
§ 890.3850 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).
0
Image /page/0/Picture/1 description: The image shows a logo for Maxhealth Medical Products. The logo features three stick figures with their arms raised, connected by a horizontal line. To the right of the stick figures, the text "Maxhealth" is written in a bold font, with the trademark symbol next to it. Below "Maxhealth", the text "User Friendly Medical Products" is written in a smaller font.
MAXHEALTH CORPORATION
15F-6, NO. 81. SEC 1, HSIN TAI WO RD., HSI CHIF
P.O. BOX 2-78, HSI CHIH, TAIPEI HSIEN, TAIWAN R.O.C.
TEL: 886-2-26984171(Rep.)
FAX: 886-2-26981300
886-2-26982486
510(k) SUMMARY "
MAR 0 1 2007
January 10, 2007
Submitter's Name: MAXHEALTH CORP.
15F-6, No.81, Hsin Tai Wu Rd., Sec. 1, His Chih, Taipei Hsien, Taiwan, 22101. ROC
Date summary prepared:
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
MAXHEALTH Mechanical Wheelchair, K1 Mechanical Wheelchair Mechanical Wheelchair, Class I, 21 CFR 890.3850
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 MAXHEALTH Mechanical Wheelchair, K1 is indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.
Performance Testing:
MAXHEALTH Mechanical Wheelchair, K1 meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.
Legally marketed device for substantial equivalence comparison:
JAN MAO Wheelchair JMC612-FL318EPP (K062218 )
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its head turned to the left and wings outstretched. The eagle is composed of three thick, curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Maxhealth Corporation % Roc Chinese-Europe Industrial Research Society Jen Ke-Min No. 58, Fu-Chiun Street Hsin-Chu City China (Taiwan)
MAR 0 1 2007
Re: K070176
Trade/Device Name: MAXHEALTH Mechanical Wheelchair, K1 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: January 10, 2007 Received: January 18, 2007
Dear Jen Ke-Min:
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.
2
Page 2 - Jen Ke-Min
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 (240) 276-0120 . 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
for
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows the logo and contact information for Maxhealth Corporation. The logo includes a stylized graphic of three figures holding hands, along with the company name and the tagline "User Friendly Medical Products." The contact information includes the address: 15F-6, NO. 81, SEC 1, HSIN TAI WU RD., HSI CHIH, P.O. BOX 2-78, HSI CHIH, TAIPEI HSIEN, TAIWAN R.O.C., as well as the telephone and fax numbers: TEL: 886-2-2 and FAX: 886-2-2, and 886-2-2.
TEL: 886-2-26984171(Rep.)
FAX: 886-2-26981300
886-2-26982486
Indications for Use
510 (K) Number ( If Known ):
Device Name: MAXHEALTH Mechanical Wheelchair, K1
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)
Concurrence of CDRH, Office of Device Evaluation (ODE) | |
---|---|
(Division Sign-Off) | |
Division of General Restorative, | |
and Neurological Devices | |
Page 1 of 1 | |
510(k) Number | K070176 |
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