Interesting. This appears to be a new product from Bioelectronics:
Manufacturers Name Address Bioelectronics Corporation 4539 Metropolitan Court Frederick, MD, 21704 United States Of America Products 1 . Hand-held deep-tissue electromagnetic stimulator Product Type Single Device Product Effective Date 3/03/2021 GMDN 35169 Hand-held deep-tissue electromagnetic stimulator Intended Purpose Adjunctive treatment of postoperative pain. Specific Conditions No Specific Conditions included on Record
In the 11/25 chairman letter, it was mentioned they needed the MDSAP certification to sell in Australia and Canada among other countries. I hope this is the one they mentioned. Great find!
Thanks dblock, As NHNBS mentioned this sounds like the RecoveryRx
The Aussies just have a unique way of describing it.
ActiPatch is already Cleared in Australia as Mundi has been selling it there.
The MDSAP is a relatively new international regulatory system that is gaining subscribers but I don't think it has been mandated yet by the countries supporting it.
What caught my eye was the 'Sponsor', LMT Surgical Pty Ltd, on the TGA form. This very well could be a New BIEL Partner.
Australia Therapeutic Goods describes a 'Sponsor' as:
"A sponsor is a person or company who does one or more of the following:
Exports therapeutic goods from Australia Imports therapeutic goods into Australia Manufactures therapeutic goods for supply in Australia or elsewhere Arranges for another party to import, export or manufacture therapeutic goods."
The one that fits for LMT Surgical is Importer.
LMT Surgical describes its self below. It sounds like RecoveryRx would be an excellent addition to their Product Line.
WHO WE ARE With more than 20 years’ experience, LMT Surgical has been providing products and services to the Orthopaedic, Spine, Neuro, Robotics, Plastics, Biologics, Sports Medicine and Aesthetics communities of Australia and New Zealand.
We are proud to offer a product portfolio which covers most pathologies and philosophies required by these medical practitioners, taking pride in involving ourselves in partnering with healthcare professionals throughout their careers, to achieve the best outcomes for clinicians and their patients.