Principle Business Ent.
Country not established
- Devices
- 3
What Principle Business Ent. makes
Principle Business Ent. manufactures disposable incontinence products, including the ROLL-A-SET absorbent pads, the TRANQUILITY incontinence belt system, and the INCONTINENT PAD & BELT for adult use. These items are designed for managing bladder or bowel incontinence, providing absorbency and secure attachment for daily wear.
The company’s products are regulated under the FDA’s 510(k) pathway, with devices classified as Class I and Class II. The portfolio is listed in the FDA’s 510(k) clearance registry, and the manufacturer is based in the United States.
Catalogue
Roll-A-Set Ref K810918
Regimes: 510(k) Registry: 510(k)Tranquility Ref K843869
Regimes: 510(k) Registry: 510(k)Incontinent Pad & Belt Ref K810544
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Principle Business Ent. have in the registry?
The registry currently lists 3 devices for Principle Business Ent.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Principle Business Ent.'s devices?
Among its 3 most recently registered devices, Principle Business Ent. has devices listed in FDA 510(k) (3 devices).
What risk classes do Principle Business Ent.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Principle Business Ent.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Principle Business Ent. in the registry?
The most recently registered devices listed for Principle Business Ent. include ROLL-A-SET, TRANQUILITY and INCONTINENT PAD & BELT.