Biosonics, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Biosonics, Inc. makes
Biosonics, Inc. manufactures medical devices for urinary incontinence and pelvic floor rehabilitation, including the Continence Control System (CCS), Anotron Incontinence Control System, Sphincter Training System, and Salitron System. These products are designed to provide external neuromuscular stimulation and biofeedback for bladder and sphincter control training.
The company’s devices are classified as Class II under FDA regulations, with some models authorised via 510(k) and others through PMA pathways. The portfolio is listed in the FDA’s regulatory databases, and the manufacturer is based in the United States.
Catalogue
The Biosonics Continence Control System Ccs(Tm) Ref K864448
Regimes: 510(k) Registry: 510(k)Anotron(R) Incontinence Control System Ref K882555
Regimes: 510(k) Registry: 510(k)Biosoics Sphincter Training System Ref K862683
Regimes: 510(k) Registry: 510(k)Salitron System Ref P860067
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Biosonics, Inc. have in the registry?
The registry currently lists 4 devices for Biosonics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biosonics, Inc.'s devices?
Among its 4 most recently registered devices, Biosonics, Inc. has devices listed in FDA 510(k) (3 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Biosonics, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Biosonics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biosonics, Inc. in the registry?
The most recently registered devices listed for Biosonics, Inc. include THE BIOSONICS CONTINENCE CONTROL SYSTEM CCS(TM), ANOTRON(R) INCONTINENCE CONTROL SYSTEM, BIOSOICS SPHINCTER TRAINING SYSTEM and SALITRON SYSTEM.