DonJoy was brought in by Scott to Market their PEM

DonJoy was brought in by Scott to Market their PEMF Wraps

DonJoy would fall under the Scott Specialty registration.

Scott & SAI are listed on the Establishment Registration Device Listing.

I am not aware of the specifics on when the GUDID is required and when the Establishment Registration is required.

I still feel strongly that the delay with SAI & DonJoy is due to a supply issue. A company is not going to spend big $$$ on Launching a new product if there are questions about the ability to produce that product.

I have been shopping for a new printer the last few days and I am finding 'Out of Stock' on many products. I talked with a Best Buy Rep & he said it is not just us, or just Canon or Brother, shortages industry wide.

Almost everything that uses Chips has been affected so it would be no surprise if BIEL was facing the same challenges in buying parts to produce the ActiPatch.

If this theory is correct I am sure Scott/DJO & SAI are disappointed in the delay but since this is a well publicized issue, and I am sure DJO & SAI are in similar situations with some of their other products, they understand that it is not a problem BIEL caused.

Here are the Establishment Registrations for 'PQY', Airway is the Canadian Branch of SAI:

AIRWAY SURGICAL APPLIANCES LTD. CANADA
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
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
Complaint File Establishment

SCOTT SPECIALTIES, INC. KS/USA
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
1511629 2021
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Repackager/Relabeler

Enter 'PQY' in the 'Product Code' of this Database,
https://www.accessdata.fda.gov/scripts/cdrh/c...fRL/rl.cfm