Another Piece of the Puzzle The FDA requires th
Post# of 8565
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Posted On: 01/24/2022 11:55:35 PM
Another Piece of the Puzzle
The FDA requires those that are involved in the Manufacture, Import, or Repackaging of Medical Devices to register every year and pay a $5600 fee.
A search of the 'Establishment Registration & Device Listing' under the 'PQY' Product Code, all BIEL & affiliates, shows everyone is up to date with their 2022 Registration except BIEL's manufacturer, CICD.
This could be related to BIEL's recent shake up with R&D, moving to expert Researchers in specific fields. Is the reason for the R&D changes the same reason BIEL's manufacturing may be moving way from CICD?
Notice SAI and their Canadian branch Airway Surgical, who first registered in 2021 but have not launched their Products yet, have paid their 2022 fees. This is a good indication that they will launch this year.
AIRWAY SURGICAL APPLIANCES LTD . CANADA (branch of SAI)
9611956 2022
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Repackager/Relabeler
BIOELECTRONICS CORPORATION MD/USA
3004837702 2022
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain - ActiPatch
Manufacturer
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Manufacturer; Specification Developer
CICD TECHNOLOGIES LTD CHINA
3017820570 2021
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Contract Manufacturer
KT Health, LLC UT/USA
3007282994 2022
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Complaint File Establishment
SCOTT SPECIALTIES, INC . KS/USA (DonJoy operates as an agent of Scott)
1933909 2022
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Repackager/Relabeler
SCOTT SPECIALTIES, INC . KS/USA
1917910 2022
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Repackager/Relabeler
SURGICAL APPLIANCE INDUSTRIES, INC . OH/USA
1511629 2022
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Repackager/Relabeler
https://www.accessdata.fda.gov/scripts/cdrh/c...fRL/rl.cfm (enter 'PQY' under 'Product Code and hit 'Search')
The FDA requires those that are involved in the Manufacture, Import, or Repackaging of Medical Devices to register every year and pay a $5600 fee.
A search of the 'Establishment Registration & Device Listing' under the 'PQY' Product Code, all BIEL & affiliates, shows everyone is up to date with their 2022 Registration except BIEL's manufacturer, CICD.
This could be related to BIEL's recent shake up with R&D, moving to expert Researchers in specific fields. Is the reason for the R&D changes the same reason BIEL's manufacturing may be moving way from CICD?
Notice SAI and their Canadian branch Airway Surgical, who first registered in 2021 but have not launched their Products yet, have paid their 2022 fees. This is a good indication that they will launch this year.
AIRWAY SURGICAL APPLIANCES LTD . CANADA (branch of SAI)
9611956 2022
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Repackager/Relabeler
BIOELECTRONICS CORPORATION MD/USA
3004837702 2022
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain - ActiPatch
Manufacturer
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Manufacturer; Specification Developer
CICD TECHNOLOGIES LTD CHINA
3017820570 2021
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Contract Manufacturer
KT Health, LLC UT/USA
3007282994 2022
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Complaint File Establishment
SCOTT SPECIALTIES, INC . KS/USA (DonJoy operates as an agent of Scott)
1933909 2022
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Repackager/Relabeler
SCOTT SPECIALTIES, INC . KS/USA
1917910 2022
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Repackager/Relabeler
SURGICAL APPLIANCE INDUSTRIES, INC . OH/USA
1511629 2022
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Repackager/Relabeler
https://www.accessdata.fda.gov/scripts/cdrh/c...fRL/rl.cfm (enter 'PQY' under 'Product Code and hit 'Search')
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