Class I - General controls

SpaceLabs’ Arkon anesthesia system recalled again

The FDA  has slapped SpaceLabs Healthcare with a Class 1 recall of its Arkon anesthesia delivery system for going into a “failed state” on numerous occasions since 2013. The recall covers 253 units. No injuries or deaths were reported. During the failed state, the mechanical ventilation function stops working while the machine is in use

FDA extends UDI deadline for Class I devices

By Stewart Eisenhart, Emergo Group US Food and Drug Administration medical device regulators have extended Unique Device Identification (UDI) labeling and related compliance deadlines for lower-risk devices to late 2022 in order to fully standardize and optimize UDI data already collected on high-risk devices. Get the full story here at the Emergo Group’s blog. The

FDA extends UDI compliance date for low risk devices

Labelers of class I and unclassified devices recently got a reprieve when FDA announced an extension of the compliance date for unique device identification (UDI). Makers of devices such as manual surgical instruments and mechanical wheelchairs will have 2 extra years to get these devices submitted to the Global unique device identification database (GUDID), FDA announced last

Design for people, not medical conditions: Motivo reimagines the walker

Motivo Tour is like no walker you’ve ever seen. It is not a cage of connected metal tubes. Instead, it is a lightweight unibody design that comes with customizable paneling, polychromatic colors and some important design features that make life easier for both users and caregivers. “No one really seemed interested in redesigning the walker,”

Are the BRIC markets still worth the effort?

Stewart Eisenhart / Senior Regulatory Analyst / Emergo Group If the title of this article sounds pessimistic, it’s for a reason. Compared to the highly evolved medical device markets in the U.S., Europe and Japan, the growing BRIC markets–Brazil, Russia, India and China–continue to perplex new entrants. The BRIC markets have long been pursued by device

GlobTek presents its latest level VI AC/DC adapter and connverter

T-43086-WWVV-X.X-Q Model is an addition to GlobTek’s Level VI compliant GT-43086 family and represents GlobTek’s 6 Watt wall plug-in series of AC/DC adapters (power supplies and chargers) with International Interchangeable blades. GlobTek’s changeable input blade system with individual field replaceable input plugs, including: North America and Japan NEMA 1-15P, Australian, UK BS 1363, European CEE

310 Watt desktop medical power supply meets efficiency level VI requirements

Power Partners releases a new 310 Watt medical grade desktop power supply from their PEAMD Series of AC and DC adapters. The 310 Watt unit is packed for ideal performance inside a compact case measuring 7.8 x 4 x 2 in. with a weight of only 3 lbs. The PEAMD310 Series is approved to the latest