Intelifuse, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Intelifuse, Inc. makes
Intelifuse, Inc. manufactures the WarmSystem with StimLinks, a device designed for thermal and neuromuscular stimulation, likely used in wound care or tissue healing applications.
The company’s portfolio is regulated under FDA 510(k) clearance as Class II devices and is based in the United States.
Catalogue
Intelifuse, Inc., Warmsystem With Stimulinks Ref K060014
Regimes: 510(k) Registry: 510(k)Intelifuse, Inc. Warm System With Stimulinks Ref K051408
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Intelifuse, Inc., initiated on 2008-07-30. By recorded status: 2 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2008
- 30 Jul 2008 Z-1032-2009 Unclassified (pre-2012) Terminated Manufacturing specification for drill bit was incorrect which, when used in conjunction with the drill guide, could cause the production of metal shavings.
- 30 Jul 2008 Z-1033-2009 Unclassified (pre-2012) Terminated Manufacturing specification for drill bit was incorrect which, when used in conjunction with the drill guide, could cause the production of metal shavings.
Frequently asked questions
How many devices does Intelifuse, Inc. have in the registry?
The registry currently lists 2 devices for Intelifuse, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Intelifuse, Inc.'s devices?
Among its 2 most recently registered devices, Intelifuse, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Intelifuse, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Intelifuse, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Intelifuse, Inc.?
FDA recall records list 2 recalls initiated by Intelifuse, Inc., the most recent initiated on 30 Jul 2008. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Intelifuse, Inc. in the registry?
The most recently registered devices listed for Intelifuse, Inc. include INTELIFUSE, INC., WARMSYSTEM WITH STIMULINKS and INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS.