UL, a global safety science company, announced that Tekna Manufacturing Private Limited (Tekna) has earned the UL Mark for its hyperbaric chambers. The hyperbaric chambers cater to user segments involving scuba divers, navy personnel, and patients with chronic or nonhealing ulcers and burns.
Tekna manufactures hyperbaric chambers in India for the global market. UL tested Tekna's multiplace and monoplace hyperbaric chambers for electromagnetic interference, electrical, mechcal, and fire safety in line with IEC 60601 family of test standards before assigning the UL Mark.
UL Marks appear on tens of billions of products globally. UL also completed product evaluation for Tekna under the International Electrotechnical Commission for Electrical Equipment Certification Body (IECEE CB) scheme. Apart from product qualification, UL provided regulatory support to Tekna by certifying them for the Medical Device Single Audit Program (MDSAP) requirements.
UL's Healthcare and Life Sciences business worked closely with Tekna to support its market access plan, and works with MedTech, health tech, pharmaceuticals and biotech, healthcare, health, and wellness retail orgzations on aspects ranging from conceptualization to commercialization of medical devices.
Srinivasa Desikan, UL's Director and Business Head for South Asia, said, "Obtaining the UL Mark is remarkable, it is the most accepted certification mark in the U.S. This mark signifies high standards of compliance for subsistence and components that can be used in production. The UL Mark and IECEE CB compliance helps support Tekna's product differentiation efforts and creates trust among its customers from a safety perspective. While testing was completed in India, the products can be sold by Tekna globally."
Sriram Narasimhan, Director at Tekna, said, "We are delighted that our product is certified with the UL Mark, a globally accepted certification mark. This UL Mark and CB test report will allow us to meet compliance requirement in countries like Canada, the U.S. and Japan, as well as provide us with improved access to other global markets."
Globally, there are only a select number of manufacturers of hyperbaric chambers. They are used in hospitals to treat various conditions but predominantly to heal chronic or nonhealing ulcers commonly seen in diabetic patients. Patients are pressurized up to three times the normal atmospheric pressure inside the chamber while breathing medical grade oxygen.
Besides wound healing, it is useful in treating burns, compromised grafts and flaps, and other treatments listed by the Undersea and Hyperbaric Medical Society (UHMS) like bubbles of air in blood vessels and wounds that do not heal due to diabetes or radiation injury. With evolving research, the number of treatments is growing. The therapy is used to treat decompression sickness that arises from deep-sea diving and is used by various navies around the world.
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( With inputs from ANI )