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What Does it Mean to be a Class II Medical Device?

Just How Clinical Gadgets are Categorized:

Influence Applications trauma treatment devices (ImPACT, ImPACT Pediatric, as well as ImPACT Quick Test) are all Class II Medical Devices. Various other instances of Class II Medical Devices are mixture pumps as well as high blood pressure cuffs.

FDA removed clinical gadgets are identified relying on their degree of danger: Class I (reduced to modest danger), Class II (modest to high threat), or Class III (high threat).

What does it suggest to be a Class II Medical Device?

As an FDA removed Class II Medical Device firm, ImPACT Applications items have actually gone through comprehensive screening and also evaluation upon first clearance as well as are constantly kept track of for conformity. Our items need to abide by all fundamental laws such as great production techniques, honest advertising and marketing insurance claims, and also reporting poor results, while additionally satisfying extra demands such as professional test information, software program screening, as well as danger administration.