KT's 2022 Establishment filing had the same designation
srinsocal
Monday, June 13, 2022 10:38:24 AM
Post#
292490
of 306549
FDA Database Confirms BIEL's OEM Partners
"Owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA. This process is known as establishment registration"
The annual registration user fee for fiscal year 2022 follows:
Year FY 2022
Fee $5,672
Establishment Registration and Device Listing for the 'PQY' (ActiPatch) Product Code:
AIRWAY SURGICAL APPLIANCES LTD. CANADA
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
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 is Scott's Marketing partner)
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
