Diane Horwitz

FDA Filings

This page includes the latest FDA filings for Diane Horwitz. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3006223078
FEI Number3006223078
NameDiane Horwitz
Owner & Operator3J TECH CO., LTD.
Contact Address342 FUSHING NORTH ROAD 2 F. --
TAIPEI TW-TPE Taipei - Special Municipality 104 TW
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5 Lake Como Ct.
Greenville, SC 29609 US
Establishment Type
  • Export Device to the United States But Perform No Other Operation on Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number3008955719
FEI Number3008955719
NameDiane Horwitz
Owner & OperatorRapid Aid Corp.
Contact Address4120A Sladeview Crescent
Mississauga CA-ON Ontario L5L5Z3 CA
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5 Lake Como Ct.
Greenville, SC 29609 US
Establishment Type
  • Manufacture Medical Device
  • Foreign Private Label Distributor
  • Complaint File Establishment per 21 CFR 820.198



Registration Number3008819648
FEI Number3008819648
NameDiane Horwitz
Owner & OperatorF.R.GALANTAI MANUFACTURING COMPANY LIMITED
Contact Address11 Bancroft Crescent
Auckland NZ-AUK Auckland 0602 NZ
Official Correspondent
  • Rod Galantai
  • 64-9-8189558-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5 Lake Como Ct
Greenville, SC 29609 US
Establishment TypeManufacture Medical Device



Registration Number9611557
FEI Number3003255510
NameDiane Horwitz
Owner & OperatorMORGAN INNOVATION AND TECHNOLOGY LTD.
Contact AddressPERTERSFIELD BUSINESS PARK BEDFORD ROAD
PETERSFIELD GB-HAM Hampshire GU32 3QA GB
Official Correspondent
  • Nigel D CLARKE
  • 044-1730-895900-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5 Lake Como Ct.
Greenville, SC 29609 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number3014982528
FEI Number3014982528
NameDiane Horwitz
Owner & OperatorRapid Aid Corp.
Contact Address4120A Sladeview Crescent
Mississauga CA-ON Ontario L5L5Z3 CA
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5 Lake Como Ct.
Greenville, SC 29609 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Diane Horwitz [Rapid Aid Corp.]
Rapid Aid Face Shield2020-04-08
Diane Horwitz [Rapid Aid Corp.]
Rapid Aid Face Shield2020-04-08
Diane Horwitz [Rapid Aid Corp.]
Infant Transport Mattress Warmer2017-11-30
Diane Horwitz [Rapid Aid Corp.]
Infant Transport Mattress Warmer2017-11-30
Diane Horwitz [Rapid Aid Corp.]
Infant Transport Mattress Warmer, 1017 CH2017-11-30
Diane Horwitz [Rapid Aid Corp.]
Infant Transport Mattress Warmer, 1017 CH2017-11-30
Diane Horwitz [F.R.GALANTAI MANUFACTURING COMPANY LIMITED]
The PULL THRU?2016-12-01
Diane Horwitz [F.R.GALANTAI MANUFACTURING COMPANY LIMITED]
Stubby Brush2016-12-01
Diane Horwitz [Rapid Aid Corp.]
Infant Heel Warmer, with Disc2015-12-08
Diane Horwitz [Rapid Aid Corp.]
Infant Heel Warmer, with Disc2015-12-08
Diane Horwitz [MORGAN INNOVATION AND TECHNOLOGY LTD.]
Neurotherm2014-10-03
Diane Horwitz [Rapid Aid Corp.]
Infant Heel Warmer2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Infant Heel Warmer2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Reusable Hot & Cold Gel Pack2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Reusable Hot & Cold Gel Pack2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Reusable Hot & Cold Compress Wrap2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Reusable Hot & Cold Compress Wrap2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Reusable Cold Gel Pack2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Reusable Cold Gel Pack2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Plantar Pack2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Plantar Pack2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Natural Therapeutic Oat bag2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Natural Therapeutic Oat bag2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Foot Pain Cold Pack2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Foot Pain Cold Pack2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Dorsum Pack2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Dorsum Pack2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Cold Slipper2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Cold Slipper2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Cold Pocket2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Cold Pocket2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Calf/Shin Pack2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Calf/Shin Pack2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Ankle Pack2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Ankle Pack2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Achilles Pack2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Achilles Pack2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Instant Warm Perineal Pack with self- adhesive strip2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Instant Warm Perineal Pack with self- adhesive strip2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Instant Warm Pack2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Instant Warm Pack2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Instant Hot Pack2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Instant Hot Pack2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Instant Extra Warm Pack2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Instant Extra Warm Pack2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Instant Extra Hot Pack2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Instant Extra Hot Pack2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Instant Cold Perineal Pack with self- adhesive strip2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Instant Cold Perineal Pack with self- adhesive strip2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Instant Cold Pack2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Instant Cold Pack2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Instant Cold Pack with self- adhering wrap2008-12-29
Diane Horwitz [Rapid Aid Corp.]
Instant Cold Pack with self- adhering wrap2008-12-29
Diane Horwitz [Rapid Aid Corp.]
92401, Ecolab Instant cold pack,2008-12-29
Diane Horwitz [Rapid Aid Corp.]
92401, Ecolab Instant cold pack,2008-12-29
Diane Horwitz [MORGAN INNOVATION AND TECHNOLOGY LTD.]
Neurotherm2008-06-11

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