Mark One Healthcare Products
Country not established
- Devices
- 5
What Mark One Healthcare Products makes
Mark One Healthcare Products manufactures disposable medical textiles, including modesty drapes, various types of absorbent incontinence products, non-sterile pressure bandages (Parema K Band), skin pressure protectors, and masterhinge devices for patient positioning and support.
The company’s portfolio is regulated under FDA Class I, Class II, and Unclassified (U) devices, with products listed via the 510(k) pathway. These devices are intended for use in clinical and homecare settings, and the company is based in the United States.
Catalogue
Drapes, Modesty Ref K770396
Regimes: 510(k) Registry: 510(k)Multiple-Various Types Of Absorbent Incontinence Ref K891986
Regimes: 510(k) Registry: 510(k)Parema K Band Non-Sterile Ref K833867
Regimes: 510(k) Registry: 510(k)Skin Pressure Protectors Ref K761268
Regimes: 510(k) Registry: 510(k)Masterhinge Ref K833084
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mark One Healthcare Products have in the registry?
The registry currently lists 5 devices for Mark One Healthcare Products. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mark One Healthcare Products's devices?
Among its 5 most recently registered devices, Mark One Healthcare Products has devices listed in FDA 510(k) (5 devices).
What risk classes do Mark One Healthcare Products's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Mark One Healthcare Products's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mark One Healthcare Products in the registry?
The most recently registered devices listed for Mark One Healthcare Products include DRAPES, MODESTY, MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE, PAREMA K BAND NON-STERILE and SKIN PRESSURE PROTECTORS.