Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043439

FEI Number

3004411059

Entity Name

Wellell Inc.

City/State/Country

NEW TAIPEI CITY, TW

Establishment Address

No. 9, MIN SHENG ST., TU-CHENG, NEW TAIPEI CITY 236044, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Wellell Inc. (Owner Number: 9001426)

Owner / Operator Contact Address

No. 9, MIN SHENG ST., TU-CHENG,, NEW TAIPEI CITY, TW-TPE 236044, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

WiZARD 510 Nasal Mask M Size WiZARD 510 Nasal Mask L Size WiZARD 510 Nasal Mask( M/L) SM00018, M Nasal Pillows Cushion SM00023, Headgear Set, Lavender SM00020, XS Nasal Pillows Cushion SM00022, Elbow Connector with Short Tube SM00017, L Nasal Pillows Cushion SM00024, Headgear Set, Light Blue SM00021, Mask Frame SM03001, Mr. WiZARD 230 Nasal Pillows Mask with Headgear SM00019, S Nasal Pillows Cushion WiZARD 310 Nasal Mask WiZARD 320 Full Face Mask WiZARD 320 Full Face Mask(S/M/L) WiZARD 310 Nasal Mask(S/M/L) WiZARD 310 Nasal Mask(S) WiZARD 310 Nasal Mask(M) WiZARD 320 Full Face Mask(S) WiZARD 320 Full Face Mask(L) WiZARD 320 Full Face Mask(M) iCH Auto Mini Star Minicare VenAir, Sequential Compression System XT Heated Humidifier (9S-006500) WiZARD 210 Nasal Mask (XS) (SM01011) WiZARD 210 Nasal Mask (M) (SM01009) WiZARD 220 Full Face Mask (L) (SM02010) WiZARD 220 Full Face Mask (S) (SM02012) WiZARD 210 Nasal Mask (L) (SM01008) WiZARD 220 Full Face Mask (M) (SM02011) WiZARD 210 Nasal Mask (S) (SM01010) SM00005, WiZARD 220 Full Face Mask Cushion, M SM00016, Small Silicon Tubing SM00006, WiZARD 220 Full Face Mask Cushion, S SM00003, WiZARD 210 Nasal Mask Cushin, S SM00030, WiZARD 210 Nasal Mask Cushin, XS SM00001, WiZARD 210 Nasal Mask Cushin, L SM00004, WiZARD 220 Full Face Mask Cushion, L SM00002, WiZARD 210 Nasal Mask Cushin, M Procare Auto G3 Seat cushion

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2020-11-02
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2013-06-13
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2019-06-04
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2015-03-20
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	1996-07-17
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2025-12-02
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2007-12-25
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2011-11-14
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2025-07-22

Official Correspondent

Chieh Yang

US Agent Details

Elsa Chu Business: WELLELL AMERICA CORP. Email: elsa.chu@wellell.com Phone: (714) 6713818

Related Public Records

Same Entity

Wellell Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006339858	Apex Medical (Kunshan) Corp.	Kunshan City Jiangsu, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24
K082979	Resmed, Ltd.	S8 ADVANCE	2009-01-02
K203126	Resmed Pty , Ltd.	S10 Kirra	2020-12-18
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043439. Last updated year: 2026. Please use registration number 8043439 when referencing this establishment in official correspondence.