Prism Technologies, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Prism Technologies, Inc. makes
Prism Technologies, Inc. manufactures reusable thermal therapy devices, including gel-based packs for heating (e.g., Instant Warm Gel Pack) and cooling (e.g., ColdGel, Instant ColdGel), as well as a portable vacuum system (MityVac) for removing excess moisture from garments and medical textiles. The company also produces a garment warmer (TransWarmer) designed for medical and industrial applications to maintain or restore body temperature in patients or workers.
The company’s products are regulated under the FDA’s 510(k) pathway, with devices classified as Class I (general controls) and Class II (special controls). These products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The manufacturer is based in the United States.
Catalogue
Instant Warm Gel Pack Ref K912715
Regimes: 510(k) Registry: 510(k)Mityvac Ref K980212
Regimes: 510(k) Registry: 510(k)Coldgel Ref K953542
Regimes: 510(k) Registry: 510(k)Transwarmer Ref K934631
Regimes: 510(k) Registry: 510(k)Instant Coldgel Ref K953541
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Prism Technologies, Inc. have in the registry?
The registry currently lists 5 devices for Prism Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Prism Technologies, Inc.'s devices?
Among its 5 most recently registered devices, Prism Technologies, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Prism Technologies, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Prism Technologies, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Prism Technologies, Inc. in the registry?
The most recently registered devices listed for Prism Technologies, Inc. include INSTANT WARM GEL PACK, MITYVAC, COLDGEL and TRANSWARMER.