Graham-Field, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Graham-Field, Inc. makes
Graham-Field, Inc. manufactures transcutaneous electrical nerve stimulation (TENS) devices for chronic pain relief, medication compressors with disposable nebulizers for respiratory therapy, and calamine-based bandages and dressings for wound care. Their product line also includes electronic stethoscopes for auscultation and a series of cardiac monitoring devices labeled as Cardisunny models. Additionally, they produce Unna boot dressings with calamine for leg ulcer management.
The company’s devices are classified under FDA categories Class I, Class II, and Unclassified (U), with most submissions supported by 510(k) clearances. Their products are listed in the FDA’s 510(k) registry. The manufacturer operates from the United States.
Catalogue
Tens Device For Relief Of Chronic Pain, Modified Ref K924876
Regimes: 510(k) Registry: 510(k)John Bunn Neb-U-Lite Ii Medication Compressor With Disposable Nebulizer, Model #jbo-112-009 Ref K970035
Regimes: 510(k) Registry: 510(k)Medicopaste Bandage With Calamine/Modification Ref K904904
Regimes: 510(k) Registry: 510(k)Cardisuny 501BIII Ref K901948
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Cardisuny, 501BX Ref K900849
Regimes: 510(k) Registry: 510(k)Cardisuny 501AB Ref K901947
Regimes: 510(k) Registry: 510(k)Unna Boot Dressing W/Calamine Ref K883224
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Graham-Field, Inc. have in the registry?
The registry currently lists 8 devices for Graham-Field, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Graham-Field, Inc.'s devices?
Among its 8 most recently registered devices, Graham-Field, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Graham-Field, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Graham-Field, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Graham-Field, Inc. in the registry?
The most recently registered devices listed for Graham-Field, Inc. include TENS DEVICE FOR RELIEF OF CHRONIC PAIN, MODIFIED, JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009, MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION and CARDISUNY 501BIII.