Karlen Mfg., Inc.
Country not established
- Devices
- 1
What Karlen Mfg., Inc. makes
Karlen Mfg., Inc. manufactures OPTI PADS, a type of medical electrode designed for use in electrotherapy applications, including transcutaneous electrical nerve stimulation (TENS) and muscle stimulation therapies.
The company’s products are regulated as Class II devices under FDA guidelines, with individual devices authorised via the 510(k) clearance process. The manufacturer is based in the United States.
Catalogue
Opti Pads Ref K950940
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Karlen Mfg., Inc. have in the registry?
The registry currently lists 1 device for Karlen Mfg., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Karlen Mfg., Inc.'s devices?
Among its 1 most recently registered device, Karlen Mfg., Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Karlen Mfg., Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Karlen Mfg., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Karlen Mfg., Inc. in the registry?
The most recently registered devices listed for Karlen Mfg., Inc. include OPTI PADS.