Peleg Intl. Co.
CanadaFDA applicant, unverified
- Devices
- 2
What Peleg Intl. Co. makes
Peleg Intl. Co. manufactures transcutaneous electrical nerve stimulation (TENS) devices, including the SKYLARK GB 1000 and SKYLARK Model 1001, designed for pain management and muscle stimulation.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company operates from the United States.
Catalogue
Skylark Gb 1000 Ref K861214
Regimes: 510(k) Registry: 510(k)Skylark Model 1001 Tens Device Ref K853898
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Peleg Intl. Co. have in the registry?
The registry currently lists 2 devices for Peleg Intl. Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Peleg Intl. Co.'s devices?
Among its 2 most recently registered devices, Peleg Intl. Co. has devices listed in FDA 510(k) (2 devices).
What risk classes do Peleg Intl. Co.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Peleg Intl. Co.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Peleg Intl. Co. in the registry?
The most recently registered devices listed for Peleg Intl. Co. include SKYLARK GB 1000 and SKYLARK MODEL 1001 TENS DEVICE.