WiZARD 520 Full Face Mask
FDA 510(k) K243023 · Wellell, Inc.
510(k) numberK243023
Submission
- Device name
- WiZARD 520 Full Face Mask
- Applicant
- Wellell, Inc.
New Taipei City, TW - Received
- September 27, 2024
- Decision date
- May 23, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZD – Ventilator, Non-Continuous (Respirator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5905
- Specialty
- Anesthesiology
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|---|---|---|---|
| K253044 | RXiBreeze PAP System (RXiBreeze 20C)BZD · Traditional | Resvent Medical Technology Co., Ltd. | 07/23/2026SE |
| K253553 | OrionBZD · Traditional | Resmed Corp | 06/04/2026SE |
| K254104 | ResScan EssentialsBZD · Traditional | Resmed Corp | 05/27/2026SE |
| K251920 | Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face…BZD · Traditional | Dcstar, Inc. | 05/21/2026SE |
| K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BZD · Traditional | BMC Medical Co., Ltd. | 04/29/2026SE |
| K252338 | MySleepDashBZD · Traditional | Somnetics International, Inc. (Dba Transcend Inc) | 04/17/2026SE |
| K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskBZD · Traditional | Sleepnet Corporation | 01/15/2026SE |
| K253939 | DeltaWave Nasal Pillow SystemBZD · Special | RemSleep Holdings, Inc. | 01/07/2026SE |
| K251770 | SleepRes PAP SystemBZD · Traditional | Sleepres, Inc. | 12/15/2025SE |
| K251657 | Personalized Therapy Comfort Settings (PTCS)BZD · Traditional | Resmed Corp | 12/05/2025SE |
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| 510(k) | Device | Decision |
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| K251466 | VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System…JOW · Special | 10/28/2025SE |
Questions and answers
When was WiZARD 520 Full Face Mask cleared by the FDA?
WiZARD 520 Full Face Mask (K243023) received a 510(k) decision of Substantially Equivalent on May 23, 2025, 238 days after the submission was received.
What is the product code of K243023?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.