FDA Establishment Registration & Device Listing

FDA Establishment Registration & Device Listing

The FDA requires anyone involved with Development, Manufacture, Repackaging of a Medical Device to Register.

BIEL is the only Cleared Medical Device under the 'PQY' Product Code. Everyone that shows up in this Database under a 'PQY' search is a BIEL Partner.

Search - Product Code 'PQY'

AIRWAY SURGICAL APPLIANCES LTD. CANADA (February addition)
9611956 2021
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Repackager/Relabeler

BIOELECTRONICS CORPORATION MD/USA
3004837702 2021
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 (BIEL's Manufacturer)
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 2021
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain - KT Recovery+ Wave
Repackager/Relabeler

SCOTT SPECIALTIES, INC. KS/USA (DonJoy added to Deal for Marketing )
1933909 2021
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Repackager/Relabeler

SCOTT SPECIALTIES, INC. KS/USA
1917910 2021
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Repackager/Relabeler

SURGICAL APPLIANCE INDUSTRIES, INC. OH/USA (February addition)
1511629 2021
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