Burke Neutech, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 7
What Burke Neutech, Inc. makes
Burke Neutech, Inc. manufactures physical therapy devices, including contrast therapy systems for muscle recovery and pain relief, such as the CONTRAST 7000 and SPORTS CONTRAST THERAPY SYSTEM ST 7000. Their portfolio also includes thermal therapy systems like the THERMAFLEX (Model SD 55 C.P.M.H.) and LSI6000 for localized heating, as well as portable cold therapy solutions such as the TS1000. Additional offerings include the NEURO-AIDE for neuromuscular stimulation and the EPILATOR for hair removal.
These devices are classified under FDA regulations as Class I or Class II, with some models requiring a 510(k) clearance. The company’s products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device authorization requirements. The manufacturer operates from the United States.
Catalogue
Neuro-Aide Ref K942926
510(k) 510(k)Contrast 7000 Therapy System Ref K943497
510(k) 510(k)Epilator Ref K952117
510(k) 510(k)Thermaflex, Model Sd 55 C.P.M.H. Ref K945803
510(k) 510(k)Sports Contrast Therapy System St 7000 Ref K955326
510(k) 510(k)LSI6000 Thermal Therapy System Ref K926151
510(k) 510(k)TS1000 Portable Disposable Cold Therapy System Ref K940160
510(k) 510(k)
Frequently asked questions
How many devices does Burke Neutech, Inc. have in the registry?
The registry currently lists 7 devices for Burke Neutech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Burke Neutech, Inc.'s devices?
Among its 7 most recently registered devices, Burke Neutech, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Burke Neutech, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Burke Neutech, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Burke Neutech, Inc. in the registry?
The most recently registered devices listed for Burke Neutech, Inc. include NEURO-AIDE, CONTRAST 7000 THERAPY SYSTEM, EPILATOR and THERMAFLEX, MODEL SD 55 C.P.M.H..