Bioness Inc.
United StatesFDA applicant, unverified
Bioness Inc. is a medical device manufacturer, with 87 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I) as of 13 Nov 2026.
- Devices
- 87
Registry facts
- Registries
- FDA GUDID 74
- EUDAMED 35
- FDA 510(k) 13
- Device classes
- FDA Class II 84
- FDA Class I 3
- Identifiers
- DUNS 182287727
What Bioness Inc. makes
Bioness Inc. manufactures transcutaneous neuromuscular electrical stimulation systems, including wireless and gait-enhancement devices designed for hand and lower-limb rehabilitation. Their portfolio also includes reusable and single-use electrical stimulation electrodes, manual and electric gait rehabilitation frames, and assistive training devices for perceptual-coordination support. Additionally, they produce hand orthoses and analgesic PENS system probes for targeted pain management.
The company’s devices are classified under FDA categories Class I and Class II, with regulatory submissions listed in the FDA’s 510(k) and UDI databases. These products are intended for physical therapy and rehabilitation applications, adhering to U.S. medical device regulations.
Catalogue
Search and filter all 87 devicesShowing 1-50 of 87
Company details
- DUNS number
- 182287727
- info@bioness.com
- Phone
- +1(800)211-9136
Frequently asked questions
How many devices does BIONESS INC. have in the registry?
The registry currently lists 87 devices for BIONESS INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list BIONESS INC.'s devices?
Among its 50 most recently registered devices, BIONESS INC. has devices listed in EUDAMED (24 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do BIONESS INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for BIONESS INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from BIONESS INC. in the registry?
The most recently registered devices listed for BIONESS INC. include L300 Go System, Left Small Lower Leg LG4-5V00, NESS H200® Wireless Hand Rehabilitation System H2W-5100, L300 Go System LG3-6800 and NESS H200® Wireless Hand Rehabilitation System H2W-5000.