FDA.report

Wellell Inc.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
80434393004411059Wellell Inc.1N2026-01-01No. 9, MIN SHENG ST., TU-CHENG NEW TAIPEI CITY TW 236044

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
120521485003663K990435BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100CAF2000-06-05
120521563150947K251466VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential ComprJOW2025-10-28
120521589975122K243023WiZARD 520 Full Face MaskBZD2025-05-23
120521373774889K193206WiZARD 510 Nasal MaskBZD2020-10-29
120521499479054K182394WiZARD 310/320 Series CPAP MaskBZD2019-05-17
120522030099830K150111Apex Medical Corp. iCH CPAP with PVA 9S-007XXX SeriesBZD2015-09-15
120521466982418K141522APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIESBZD2014-10-06
120521444087757K121642WIZARD 230 NASAL PILOW MASKBZD2013-06-06
120521526969712K120035APEX MEDICAL ICH CPAP SERIES (9S-007XXX)BZD2012-05-16
120521357401630K112079APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720BZD2012-12-06
120521773926481K103535VACPLUS SUCTION UNITJCX2011-02-24
120521089123585K103174APEX MEDICAL WIZARD SERIES CPAP MASKBZD2011-05-06
120521254891262K083656APEX MEDICAL XT AUTO CPAP 9S-005200BZD2009-04-22
120521363552864K070990APEX MEDICAL MOBINEB, 9R-027 SERIESCAF2007-05-18
120521452631921K070609APEX MEDICAL XT1 CPAP, MODEL 9S-005BZD2007-05-04
120521901607378K063268CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235BZD2007-02-23
120521310542459K062664HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004BTT2006-12-06
120521310542459K062664HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004BTT2006-12-06
120521608805463K050104APEX MEDICAL MININEB & MINIPLUSCAF2005-02-16
1205211150797801969-12-31
1205211150797801969-12-31
1205211150797801969-12-31
1205211150797801969-12-31
1205211492202091969-12-31
1205211492202091969-12-31
1205211492202091969-12-31
1205211492202091969-12-31
1205212011581221969-12-31
1205212011581221969-12-31
1205212011581221969-12-31
1205212011581221969-12-31
1205212788593741969-12-31
1205212788593741969-12-31
1205212788593741969-12-31
1205212788593741969-12-31
1205213548138481969-12-31
1205213548138481969-12-31
1205213548138481969-12-31
1205213548138481969-12-31
1205214772194531969-12-31
1205214772194531969-12-31
1205214772194531969-12-31
1205214772194531969-12-31
1205214867963641969-12-31
1205214867963641969-12-31
1205214867963641969-12-31
1205214867963641969-12-31
1205218303595741969-12-31
1205218303595741969-12-31
1205218303595741969-12-31
1205218303595741969-12-31
1205218400102031969-12-31
1205218400102031969-12-31
1205218400102031969-12-31
1205218400102031969-12-31
1205218541863391969-12-31
1205218541863391969-12-31
1205218541863391969-12-31
1205218541863391969-12-31
1205219129002031969-12-31
1205219129002031969-12-31
1205219129002031969-12-31
1205219129002031969-12-31
120521071763145
120521225168618
120521384589065

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
BZD122025-05-23
CAF32007-05-18
BTT22006-12-06
JOW12025-10-28
JCX12011-02-24

PMA

PMN

Applications

GUDID