Blue Sky Medical Group Incorporated
United StatesFDA applicant, unverified
- Devices
- 4
What Blue Sky Medical Group Incorporated makes
Blue Sky Medical Group Incorporated manufactures wound vacuum systems, including the Versatile 1 Wound Vacuum System, the Versatile 1 EZCare Wound Vacuum System, and the Bluesky Vista Wound Vacuum System (Model 100.0500), along with modifications to these systems. These devices are designed for negative pressure wound therapy to promote healing in chronic or acute wounds.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. The portfolio is listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Modification To Versatile 1 Wound Vacuum System Ref K052456
Regimes: 510(k) Registry: 510(k)Versatile 1 Wound Vacuum System Ref K042134
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Versatile 1 Ezcare Wound Vacuum System Ref K061919
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Blue Sky Medical Group Incorporated have in the registry?
The registry currently lists 4 devices for Blue Sky Medical Group Incorporated. Devices recorded under merged duplicate company entries are counted once.
Which registries list Blue Sky Medical Group Incorporated's devices?
Among its 4 most recently registered devices, Blue Sky Medical Group Incorporated has devices listed in FDA 510(k) (4 devices).
What risk classes do Blue Sky Medical Group Incorporated's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Blue Sky Medical Group Incorporated's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Blue Sky Medical Group Incorporated in the registry?
The most recently registered devices listed for Blue Sky Medical Group Incorporated include MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEM, VERSATILE 1 WOUND VACUUM SYSTEM, BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500 and VERSATILE 1 EZCARE WOUND VACUUM SYSTEM.