Biostim, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Biostim, Inc. makes
Biostim, Inc. manufactures transcutaneous electrical nerve stimulation (TENS) devices, including muscle stimulators for clinical and therapeutic use, such as the MUSCLE STIMULATOR X-10 and ANASTIM II. Their portfolio also includes reusable electrode systems like AQUAFORM ELECTRODES WITH AQUAPORE and dedicated clinical care stimulators, such as the SYSTEM 10 and CLINICAL CARE STIMULATOR.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
Muscle Stimulator X-10 Ref K840724
Regimes: 510(k) Registry: 510(k)System 10 Ref K820678
Regimes: 510(k) Registry: 510(k)Aquaform Electrodes With Aquapore Ref K844023
Regimes: 510(k) Registry: 510(k)Anastim Ii Transcutaneous Electrical Ref K802227
Regimes: 510(k) Registry: 510(k)Clinical Care Stimulator Ref K840725
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biostim, Inc. have in the registry?
The registry currently lists 5 devices for Biostim, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biostim, Inc.'s devices?
Among its 5 most recently registered devices, Biostim, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Biostim, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Biostim, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biostim, Inc. in the registry?
The most recently registered devices listed for Biostim, Inc. include MUSCLE STIMULATOR X-10, SYSTEM 10, AQUAFORM ELECTRODES WITH AQUAPORE and ANASTIM II TRANSCUTANEOUS ELECTRICAL.