Sween Corp.
United StatesFDA applicant, unverified
- Devices
- 4
What Sween Corp. makes
Sween Corp. manufactures protective and wound care products, including universal bed rail pads designed for patient safety, peristomal wafers for ostomy management, and collagen-based wound dressings for skin repair. Their portfolio also includes a wound dressing specifically formulated for critical care applications.
The company’s devices are classified under Class I and Unclassified (U) regulatory categories in the US, with several authorised via the FDA’s 510(k) pathway. Products are listed under US regulatory frameworks, and the manufacturer operates from the United States.
Catalogue
Sween Universal Bed Rail Pads Ref K810846
Regimes: 510(k) Registry: 510(k)Critic-Aid Wound Dressing Ref K912506
Regimes: 510(k) Registry: 510(k)Sween-A-Peel Peristomal Wafers Ref K840723
Regimes: 510(k) Registry: 510(k)Sween Wound Care-Collagen Wound Dressing Ref K926389
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sween Corp. have in the registry?
The registry currently lists 4 devices for Sween Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sween Corp.'s devices?
Among its 4 most recently registered devices, Sween Corp. has devices listed in FDA 510(k) (4 devices).
What risk classes do Sween Corp.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Sween Corp.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Sween Corp. in the registry?
The most recently registered devices listed for Sween Corp. include SWEEN UNIVERSAL BED RAIL PADS, CRITIC-AID WOUND DRESSING, SWEEN-A-PEEL PERISTOMAL WAFERS and SWEEN WOUND CARE-COLLAGEN WOUND DRESSING.