(238 days)
Not Found
No
The device is a medical mask designed to provide an interface for CPAP/bi-level therapy. The description focuses on its physical components, function (airflow, CO2 removal), and safety/performance tests, none of which indicate the presence of an AI model. There are explicit statements of "Not Found" for "Mentions AI, DNN, or ML".
No.
The device is a mask that provides an interface for positive airway pressure therapy but does not generate the therapeutic pressure itself.
No
This device is a CPAP mask, intended to provide an interface for positive airway pressure therapy. Its description and intended use clearly state it delivers therapy, not performs diagnosis.
No
The device is a physical CPAP mask, described with a cushion, frame, vents, and headgear. It is explicitly designed to connect to physical CPAP and bi-level systems via a 22mm breathing tube. The performance and reliability tests listed are all for physical properties of a tangible medical device (e.g., CO2 rebreathing, resistance to flow, biocompatibility, shipping, drop tests, disinfection validation). There is no mention of software components, AI, or any digital processing as part of its intended function.
No.
This device is a physical mask intended to provide an interface for CPAP/bi-level therapy. It does not perform in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
The Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. The Mask is intended for single-patient reuse in the home and multi-patient multi-use in the hospital environment. The Mask is to be used by adults weighing ≥ 30 kg whom positive airway pressure (CPAP or bi-level system) has been prescribed.
Product codes
BZD
Device Description
WiZARD 520 Full Face Mask's cushion and frame provide a secure interface between the mask and the patient's face and the flexible cushion improves seal. A series of vents on the elbow, serve as an exhalation vent to purge the exhaled carbon dioxide from the mask. The mask is designed to maintain a continuous airflow to minimize the amount of CO2 rebreathed by the patient. The mask features a wider visibility design that ensures a clear line of sight. It also includes a fabric frame equipped with 3D-shaped headgear for enhanced comfort and stability. WiZARD 520 Full Face Mask is intended for connection to a positive air pressure source such as CPAP or bi-level for the treatment of Obstructive Sleep Apnea. WiZARD 520 Full Face Mask can be linked to the CPAP or bi-level system's standard 22 mm breathing tube using a swivel hose, flexible tube, and tubing connector. Various sizes (small, medium, and large) are offered to ensure adequate fit over the extended patient population.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face
Indicated Patient Age Range
Adults weighing ≥ 30 kg
Intended User / Care Setting
Single-patient reuse in the home and multi-patient multi-use in the hospital environment.
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 testing conducted to evaluate safety and effectiveness:
Performance tests: CO2 Rebreathing, Pressure-Flow characteristics, Resistance to flow, Anti-Asphyxia valve operating pressures, Sound power level test, Sound pressure level test, Dead space test.
Biocompatibility tests: Cytotoxicity Test, Skin irritation Test, Skin sensitization Test, Leachable and extractable Test, Particulate matter (PM) Test, Volatile organic compounds (VOC) Test.
Reliability tests: Shipping test, Drop test, Temperature operation test, Sit test, Shelf life test report, Disinfection validation, Cleaning validation.
Key results: Compliance with ISO 17510:2015 CO2 requirements (
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
FDA 510(k) Clearance Letter - WiZARD 520 Full Face Mask
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 23, 2025
Wellell Inc.
Chieh Yang
Quality Engineering Manager
No. 9, Min Sheng St.,
Tu-Cheng, New Taipei City, Taiwan
New Taipei City, 236044
Taiwan
Re: K243023
Trade/Device Name: WiZARD 520 Full Face Mask
Regulation Number: 21 CFR 868.5905
Regulation Name: Noncontinuous Ventilator (IPPB)
Regulatory Class: Class II
Product Code: BZD
Dated: September 27, 2024
Received: April 21, 2025
Dear Chieh Yang:
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"
Page 2
K243023 - Chieh Yang Page 2
(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 QS 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
Page 3
K243023 - Chieh Yang Page 3
Sincerely,
Rachana Visaria -S
Rachana Visaria, Ph.D.
Assistant Director
DHT1C: Division of Anesthesia,
Respiratory, and Sleep Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K243023
Device Name: WiZARD 520 Full Face Mask
Indications for Use (Describe)
The Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. The Mask is intended for single-patient reuse in the home and multi-patient multi-use in the hospital environment.
The Mask is to be used by adults weighing ≥ 30 kg whom positive airway pressure (CPAP or bi-level system) has been prescribed.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ 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:
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"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."
Page 5
Wellell Inc. K243023
WiZARD 520 Full Face Mask
Page 1 of 8
510(k) Summary
1. Type of submission:
Traditional
2. Date of summary:
May 22, 2025
3. Submitter:
Wellell Inc.
Address: No. 9, Min Sheng St., Tu-Cheng, New Taipei City, 236044, Taiwan
Phone: +886-2-2268-5568
Fax: +886-2-2268-9662
Contact: Chieh Yang (meow.yang@wellell.com)
Job title: Quality Engineering Manager
4. Identification of the device:
| Proprietary/Trade name: | WiZARD 520 Full Face Mask |
|---|---|
| Classification product Code: | BZD |
| Regulation number: | 21 CFR 868.5905 |
| Regulation description: | Noncontinuous ventilator |
| Review panel: | Anesthesiology |
| Device class: | II |
5. Identification of the Predicate Device:
| Predicate device name: | WiZARD 310/320 Series CPAP Mask |
|---|---|
| Manufacturer: | Wellell Inc. |
| Classification product code: | BZD |
| Regulation number: | 21 CFR 868.5905 |
| Device class: | II |
| 510(k) number: | K182394 |
Page 6
Wellell Inc. K243023
WiZARD 520 Full Face Mask
Page 2 of 8
6. Device description
WiZARD 520 Full Face Mask's cushion and frame provide a secure interface between the mask and the patient's face and the flexible cushion improves seal. A series of vents on the elbow, serve as an exhalation vent to purge the exhaled carbon dioxide from the mask. The mask is designed to maintain a continuous airflow to minimize the amount of CO2 rebreathed by the patient. The mask features a wider visibility design that ensures a clear line of sight. It also includes a fabric frame equipped with 3D-shaped headgear for enhanced comfort and stability.
WiZARD 520 Full Face Mask is intended for connection to a positive air pressure source such as CPAP or bi-level for the treatment of Obstructive Sleep Apnea. WiZARD 520 Full Face Mask can be linked to the CPAP or bi-level system's standard 22 mm breathing tube using a swivel hose, flexible tube, and tubing connector. Various sizes (small, medium, and large) are offered to ensure adequate fit over the extended patient population.
7. Indication for use
The Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. The Mask is intended for single-patient reuse in the home and multi-patient multi-use in the hospital environment.
The Mask is to be used by adults weighing ≥ 30kgs whom positive airway pressure (CPAP or bi-level system) has been prescribed.
Page 7
Wellell Inc. K243023
WiZARD 520 Full Face Mask
Page 3 of 8
8. Comparison of technological characteristics with the predicate device
| Characteristic | Predicate Device WiZARD 320 CPAP Mask | Subject Device WiZARD 520 Full Face Mask | Comments |
|---|---|---|---|
| Product Code | BZD | BZD | Equivalent |
| Regulation Number | 868.5905 | 868.5905 | Equivalent |
| Indications for Use | WIZARD 310/320 series CPAP Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. These masks are intended for single-patient reuse in the home and multi-patient, multi-use in the hospital environment. These masks are to be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bi-level system) has been prescribed. | The Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. The Mask is intended for single-patient reuse in the home and multi-patient multi-use in the hospital environment. The Mask is to be used by adults weighing ≥ 30 kgs whom positive airway pressure (CPAP or bi-level system) has been prescribed. | Equivalent |
| Patient Use Type | Adult ≥ 30 kg | Adult ≥ 30 kg | Equivalent |
| Indication | Obstructive sleep apnea | Obstructive sleep apnea | Equivalent |
| Environment | Home, hospital | Home, hospital | Equivalent |
Page 8
Wellell Inc. K243023
WiZARD 520 Full Face Mask
Page 4 of 8
| Characteristic | Predicate Device WiZARD 320 CPAP Mask | Subject Device WiZARD 520 Full Face Mask | Comments |
|---|---|---|---|
| Reprocessing | Single patient reuse or multi-patient reuse | Single patient reuse or multi-patient reuse | Equivalent |
| Patient Support System | CPAP or bi-level system | CPAP or bi-level system | Equivalent |
| Principle of Operation | Mask provides an interface such that airflow from a positive pressure source is directed to the patient's nostril and is held in place with adjustable headgear that straps the mask to the face. | Mask provides an interface such that airflow from a positive pressure source is directed to the patient's nostril and is held in place with adjustable headgear that straps the mask to the face. | Equivalent |
| Use Life | 6 months after unpacking | 6 months after unpacking (or 30 cycles under disinfection) | The subject device claims to incorporate disinfection considerations. |
| Mask Size | L/M/S | L/M/S | Equivalent |
| Mask Dead Space | L: 328 ml, M: 284 ml, S: 223.8 ml | L: 271 ml, M: 228 ml, S: 211 ml | Measured dead space is disclosed in labelling in accordance with ISO 17510:2015. |
| Sterility | Non-sterile | Non-sterile | Equivalent |
| Pressure Range | 4~40 cmH2O | 4~40 cmH2O | Equivalent |
| Hose Connection | 22 mm | 22 mm | Equivalent |
| Operation Range | +5℃ to +35℃ (+41℉ to +95℉) 15% to 95% R.H (non-condensing) | +5℃ to +35℃ (+41℉ to +95℉) 15% to 95% R.H (non-condensing) | Equivalent |
Page 9
Wellell Inc. K243023
WiZARD 520 Full Face Mask
Page 5 of 8
| Characteristic | Predicate Device WiZARD 320 CPAP Mask | Subject Device WiZARD 520 Full Face Mask | Comments |
|---|---|---|---|
| Storage and Transport | -15℃ to +60℃ (+5℉ to +140℉) 10% to 90% R.H (non-condensing) | -15℃ to +60℃ (+5℉ to +140℉) 10% to 90% R.H (non-condensing) | Equivalent |
| Exhaust Flow | Pressure (cmH2O) / Flow (l/min): 4/18, 8/26, 12/32, 16/38, 20/45, 24/49, 28/53, 30/57, 32/59, 36/63, 40/66 | Pressure (cmH2O) / Flow (l/min): 4/18, 13/35, 22/48, 31/59, 40/69 | Testing and reporting have been conducted in line with ISO17510: 2015. |
| CO2 Rebreathing Normal condition | Pressure (cmH2O) / Relative CO2 increase: 4/16%, 5/14%, 10/6% | Pressure (cmH2O) / Relative CO2 increase: 4/6%, 5/5%, 10/1% | Equivalent Complies with ISO 17510:2015 CO2 requirements ( |