FDA.report

Kerry Rome

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30055452163005545216Kerry Rome1N2026-01-011525 Bluegrass LakesParkway, Suite B Alpharetta GA US 30004
30123527823012352782Kerry Rome1N2026-01-011525 Bluegrass LakesParkway, Suite B Alpharetta GA US 30004

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
661291906505641K931923DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE)GWF1993-11-09
661291370364746K926516DANTEC MAGNETIC STIMULATOR MAGPROGWF1993-08-31
1864671410423530K926516DANTEC MAGNETIC STIMULATOR MAGPROGWF1993-08-31
1864671140799838K252032T65 (9016E061-)OBP2025-07-30
661291759493123K252032T65 (9016E061-)OBP2025-07-30
661291243464443K251125MagVenture TMS Therapy SystemOBP2025-08-11
1864671888637415K251125MagVenture TMS Therapy SystemOBP2025-08-11
661291295853469K251119MagVenture TMS Therapy SystemOBP2025-08-08
1864671439238097K251119MagVenture TMS Therapy SystemOBP2025-08-08
661291084677509K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOptionQPL2023-08-25
1864671121072309K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOptionQPL2023-08-25
1864671512783775K221544MagVenture TMS Atlas Neuro Navigation SystemHAW2023-03-17
661291631434781K221544MagVenture TMS Atlas Neuro Navigation SystemHAW2023-03-17
1864671641721605K193006MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy systemQCI2020-08-09
661291956550121K193006MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy systemQCI2020-08-09
1864671458416510K173620Mag Vita TMS Therapy System w/Theta Burst StimulationOBP2018-08-14
661291934515121K173620Mag Vita TMS Therapy System w/Theta Burst StimulationOBP2018-08-14
661291125606205K172667MagVita TMS Therapy w/MagPro R20OBP2017-10-05
1864671330871724K172667MagVita TMS Therapy w/MagPro R20OBP2017-10-05
1864671745422180K171967MagVita TMS Therapy SystemOBP2017-07-25
661291771419249K171967MagVita TMS Therapy SystemOBP2017-07-25
1864671453097371K171481MagVita TMS Therapy SystemOBP2017-06-16
661291925404720K171481MagVita TMS Therapy SystemOBP2017-06-16
1864671156709203K170114MagVita TMS Therapy - w/MagPro R20OBP2017-05-01
661291214995830K170114MagVita TMS Therapy - w/MagPro R20OBP2017-05-01
1864671016443442K162873MEP MonitorGWF2017-03-31
661291871582600K162873MEP MonitorGWF2017-03-31
661292007925486K160280MagPro R20GWF2016-05-16
1864672023178157K160280MagPro R20GWF2016-05-16
661291919271412K150641MagVita TMS Therapy SystemOBP2015-07-31
1864672040019958K150641MagVita TMS Therapy SystemOBP2015-07-31
1864671011148266K091940MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTIONGWF2010-03-26
661291357893400K091940MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTIONGWF2010-03-26
661291577309828K071821COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65GWF2007-07-27
1864671835371221K071821COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65GWF2007-07-27
661291188703606K061645MAGPRO, MODEL R30GWF2006-10-31
1864672029682786K061645MAGPRO, MODEL R30GWF2006-10-31
661291113633887

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
OBP182025-08-11
GWF132017-03-31
QPL22023-08-25
HAW22023-03-17
QCI22020-08-09