(49 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or related concepts like algorithms, data sets, or image processing.
No.
A therapeutic device is typically involved in the treatment, cure, mitigation, or prevention of disease. A manual wheelchair, while aiding mobility, does not directly perform a therapeutic intervention.
No
This device, a manual wheelchair, is designed to provide mobility and support to individuals with limited sitting ability. Its function is to assist in movement, not to diagnose medical conditions.
No
The device description clearly outlines a mechanical device with physical components like a frame, wheels, seat, and brakes, and the performance studies refer to testing against physical standards for wheelchairs. There is no mention of software as a component or function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Manual Wheelchair is a mechanical device used to provide mobility to people who are limited to a sitting position. It is a physical aid for movement, not a device that analyzes biological samples.
- Intended Use: The intended use is to provide mobility, which is a physical function, not a diagnostic test.
- Lack of Relevant Information: The document lacks any mention of analyzing samples, detecting biomarkers, or performing any kind of laboratory test, which are hallmarks of IVDs.
The information provided describes a standard medical device used for physical support and mobility.
N/A
Intended Use / Indications for Use
The Manual Wheelchair is to provide mobility to persons limited to a sitting position.
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
MW18 manual wheelchair is a mechanical which is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bring the two sides together. The manual wheelchair incorporates a foldable frame, a seat, two footrests and four wheels. The larger rear wheels have push-rims of slightly smaller diameter projecting just beyond the user to manoeuvre the chair by pushing them on without requiring them to grasp the tyres. The manual wheelchairs have brakes that bear on the tyres of there are two push handles at the upper rear of the frame to allow for manual propulsion by a second person, e.g. caregiver. The wheelchair can support users of up to 120kg.
Main Components:
Main frame, back upholstery, seat upholstery, handgrip, armrest, front wheel, hand rim, crossbar, footrest, skirt guard, brake, anti-tipper (optional)
The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
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)
Non-clinical tests were conducted to verify that the subject device met all design specifications and provided support of the substantial equivalence determination. The test results demonstrated that the proposed device complies with the following standards: ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering space ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strength ISO 7176-11:2012 Wheelchairs -- Part 11: Test dummies ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces. ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling. ISO 16840-10:2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method ISO 7176-22: 2014 Wheelchairs - Part 22: Set-up procedures Bio-Compatibility tests were conducted to verify that the safety requirements, and the following standards were complied: ISO10993-5 Biological evaluations of medical devices --- Part 5: Tests for In Vitro cytotoxicity ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation not applicable The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K201461.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 11, 2024
Lichtmega Technology CO., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Co. Ltd. 14th Floor, 1500# Century Avenue Shanghai, Shanghai 200122 China
Re: K241460
Trade/Device Name: Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I, reserved Product Code: IOR Dated: May 23, 2024 Received: May 23, 2024
Dear Ivy Wang:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Tushar Bansal -S
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices
2
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Manual Wheelchair
Indications for Use (Describe)
The Manual Wheelchair is to provide mobility to persons limited to a sitting position.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
| 510(k) Summary | |||
|---|---|---|---|
| Contact Details | Prepared on: 2024-06-05 | ||
| 21 CFR 807.92(a)(1) | |||
| Applicant Name | Lichtmega Technology CO., Ltd. | ||
| Applicant Address | #101, No. 200, Cangjing Road, Songjiang District Shanghai Shanghai | ||
| China | |||
| Applicant Contact Telephone | +86-021-5789862 | ||
| Applicant Contact | Mr. Hyman Zhu | ||
| Applicant Contact Email | Hyman@lichtmega.com | ||
| Correspondent Name | Shanghai Sungo Management Consulting Co. Ltd. | ||
| Correspondent Address | 14th Floor, 1500# Century Avenue Shanghai Shanghai 200122 | ||
| China | |||
| Correspondent Contact Telephone | +86-21-58817802 | ||
| Correspondent Contact | Ms. Ivy Wang | ||
| Correspondent Contact Email | haiyu.wang@sungoglobal.com | ||
| Device Name | 21 CFR 807.92(a)(2) | ||
| Device Trade Name | Manual Wheelchair (MW18) | ||
| Common Name | Mechanical wheelchair | ||
| Classification Name | Wheelchair, Mechanical | ||
| Regulation Number | 890.3850 | ||
| Product Code(s) | IOR | ||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| K201461 | Manual Wheelchair | IOR | |
| Device Description Summary | 21 CFR 807.92(a)(4) |
MW18 manual wheelchair is a mechanical which is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bring the two sides together. The manual wheelchair incorporates a foldable frame, a seat, two footrests and four wheels. The larger rear wheels have push-rims of slightly smaller diameter projecting just beyond the user to manoeuvre the chair by pushing them on without requiring them to grasp the tyres. The manual wheelchairs have brakes that bear on the tyres of there are two push handles at the upper rear of the frame to allow for manual propulsion by a second person, e.g. caregiver. The wheelchair can support users of up to 120kg.
Main Components:
Main frame, back upholstery, seat upholstery, handgrip, armrest, front wheel, hand rim, crossbar, footrest, skirt guard, brake,
5
anti-tipper (optional)
The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
Intended Use/Indications for Use
The Manual Wheelchair is to provide mobility to persons limited to a sitting position.
Indications for Use Comparison
The proposed device has same indications for use to the predicate device. Minor difference on dimension and specifications do not affect the safety and effectiveness of the proposed device.
Technological Comparison
The proposed device is same in working principle, indications for use, technological characteristics, and is composed of the same or similar components as the predicate device. The product proposed under this premarket notification has the same or similar performance characteristics and conform to the same. Differences between the subject wheelchair and predicate devices did not raise any new concerns regarding safety and effectiveness.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Non-clinical tests were conducted to verify that the subject device met all design specifications and provided support of the substantial equivalence determination. The test results demonstrated that the proposed device complies with the following standards: ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering space ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strength ISO 7176-11:2012 Wheelchairs -- Part 11: Test dummies ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces. ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling. ISO 16840-10:2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method ISO 7176-22: 2014 Wheelchairs - Part 22: Set-up procedures Bio-Compatibility tests were conducted to verify that the safety requirements, and the following standards were complied: ISO10993-5 Biological evaluations of medical devices --- Part 5: Tests for In Vitro cytotoxicity
ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation
not applicable
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K201461.
21 CFR 807.92(a)(5)
and specifications do not
21 CFR 807,92(a)(6)
21 CFR 807.92(a)(5)