Actegy L T D

FDA Filings

This page includes the latest FDA filings for Actegy L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3010078417
FEI Number3010078417
NameGlenn Kowalski
Owner & OperatorActegy Ltd.
Contact AddressReflex Cain Road
Bracknell, Berks GB-UKM United Kingdom RG12 1HL GB
Official Correspondent
  • Roseanna Penny
  • 044-1344-636940-2027
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address6400 Shafer Court Suite 225
Des Plaines, IL 60018 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device

Registration Number3011501130
FEI Number3011501130
NameActegy Health Inc.
Owner & OperatorActegy Ltd.
Contact AddressReflex Cain Road
Bracknell, Berks GB-UKM United Kingdom RG12 1HL GB
Official Correspondent
  • Roseanna Penny
  • 044-1344-636940-2027
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address6400 Shafer Court, Suite 225
Rosemont, IL 60018 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
ACTEGY LIMITED
 Revitive Medic Coach 59212022-02-07
Actegy, Ltd.
Revitive Medic Coach (Model Number 5575AQ)2021-12-17
ACTEGY LIMITED
 Aerosure 14742021-05-12
ACTEGY LIMITED
 Revitive Electrode Body Pads 2021-05-12
ACTEGY LIMITED
 Revitive ProHealth 63022021-01-29
ACTEGY LIMITED
 Revitive Medic 59702021-01-27
ACTEGY LIMITED
 Revitive Medic Knee 57372020-10-02
ACTEGY LIMITED
 Revitive Essential 24522020-10-02
ACTEGY LIMITED
 Revitive Arthritis Knee Pads 29392020-08-05
Actegy, Ltd.
Revitive Medic Plus, Revitive Advanced 22020-05-04
ACTEGY LIMITED
 Revitive Medic Plus 31582019-10-23
Actegy Health Inc. [Actegy Ltd.]
Revitive Medic Plus2019-07-08
Actegy Health Inc. [Actegy Ltd.]
Revitive Advanced 22019-07-08
Actegy Health Inc. [Actegy Ltd.]
Revitive Medic Plus2019-07-08
Actegy Health Inc. [Actegy Ltd.]
Revitive Advanced 22019-07-08
Actegy Health Inc. [Actegy Ltd.]
Revitive Medic Plus2019-07-08
Actegy Health Inc. [Actegy Ltd.]
Revitive Advanced 22019-07-08
Actegy Health Inc. [Actegy Ltd.]
Revitive Medic Plus2019-07-08
Actegy Health Inc. [Actegy Ltd.]
Revitive Advanced 22019-07-08
Actegy, Ltd.
Revitive Medic Plus, Revitive Advanced 22019-07-05
ACTEGY LIMITED
 Revitive Advanced 26152019-05-23
ACTEGY LIMITED
 Revitive Medic 26162019-05-23
ACTEGY LIMITED
 Revitive Circulation Booster 17182019-05-23
ACTEGY LIMITED
 Revitive Electrode Body Pads 15702018-07-06
Glenn Kowalski [Actegy Ltd.]
Revitive Medic2016-09-07
Glenn Kowalski [Actegy Ltd.]
Revitive Advanced2016-09-07
Actegy Health Inc. [Actegy Ltd.]
Revitive Medic2016-09-07
Actegy Health Inc. [Actegy Ltd.]
Revitive Advanced2016-09-07
Glenn Kowalski [Actegy Ltd.]
Revitive Medic2016-09-07
Glenn Kowalski [Actegy Ltd.]
Revitive Advanced2016-09-07
Actegy Health Inc. [Actegy Ltd.]
Revitive Medic2016-09-07
Actegy Health Inc. [Actegy Ltd.]
Revitive Advanced2016-09-07
Actegy, Ltd.
Revitive Medic; Revitive MV; Revitive LV2016-03-31
Glenn Kowalski [Actegy Ltd.]
Revitive Circulation Booster2015-03-30
Actegy Health Inc. [Actegy Ltd.]
Revitive Circulation Booster2015-03-30
Glenn Kowalski [Actegy Ltd.]
Revitive Circulation Booster2015-03-30
Actegy Health Inc. [Actegy Ltd.]
Revitive Circulation Booster2015-03-30
Glenn Kowalski [Actegy Ltd.]
Aerosure Medic2015-03-30
Actegy Health Inc. [Actegy Ltd.]
Aerosure Medic2015-03-30
Actegy, Ltd
Revitive IX (OTC)2015-03-23
Actegy Ltd
AEROSURE MEDIC2014-12-19
Glenn Kowalski [Actegy Ltd.]
Revitive Electrode Pads2014-10-13
Actegy Health Inc. [Actegy Ltd.]
Revitive Electrode Pads2014-10-13
Glenn Kowalski [Actegy Ltd.]
Revitive Medic2013-07-31
Glenn Kowalski [Actegy Ltd.]
Revitive IX2013-07-31
Actegy Health Inc. [Actegy Ltd.]
Revitive Medic2013-07-31
Actegy Health Inc. [Actegy Ltd.]
Revitive IX2013-07-31
Actegy Ltd
REVITIVE IX2013-06-28

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020072027067Shanghai ,China (Mainland) -> Seattle, WashingtonELECTRODE PAD7 CTN
2019102140558Pusan,South Korea -> Seattle, WashingtonREVITIVE MEDIC (CIRCULATION BOOSTER) WITH FUL L SET OF ACCESSORIES651 PKG
2019081414398Xiamen,China (Mainland) -> Savannah, GeorgiaTOOL BAG500 CTN
201907177149Xiamen,China (Mainland) -> Savannah, GeorgiaTOOL BAG1000 CTN
201907177149Xiamen,China (Mainland) -> Savannah, GeorgiaTOOL BAG1000 CTN
2019062459739Pusan,South Korea -> Seattle, WashingtonREVITIVE MEDIC (CIRCULATION BOOSTER) WITH FUL L SET OF ACCESSORIES653 PKG
2019061743544Hong Kong,Hong Kong -> Vancouver, WashingtonCANADA MEDIC AEROSURE AEROSURE MOUTHPIECES UK40 CTN
2019061044290Xiamen,China (Mainland) -> Seattle, WashingtonTOOL BAG200 CTN
2019041847607Pusan,South Korea -> Seattle, WashingtonREVITIVE MEDIC (CIRCULATION BOOSTER) WITH FUL L SET OF ACCESSORIES657 PKG
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