Is this your brand? Sign in to claim ownership.
Sign in to claim this brandBIONESS INC.
US
Last updated May 24, 2026
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. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Bioness Inc. manufacture?
Bioness Inc. specializes in transcutaneous neuromuscular electrical stimulation (NMES) systems and related rehabilitation tools. Their portfolio includes wireless and gait-enhancement devices like the NESS H200® Wireless Hand Rehabilitation System, designed for hand and lower-limb recovery. They also produce reusable and single-use electrodes, manual and electric gait rehabilitation frames, hand orthoses, and assistive training devices for perceptual-coordination support. These devices are primarily intended for physical therapy and rehabilitation applications.
Where is Bioness Inc. based, and how does that affect its regulatory oversight?
Bioness Inc. is based in the United States, which means its devices fall under U.S. medical device regulations. The company’s products are classified under FDA categories Class I and Class II, indicating varying levels of regulatory scrutiny depending on the device’s risk profile. Since the U.S. is the manufacturer’s home country, submissions for these devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system, ensuring compliance with U.S. regulatory requirements.
Which regulatory registries list Bioness Inc.’s devices, and why?
Bioness Inc.’s devices are listed in the FDA’s 510(k) and UDI databases. The 510(k) registry includes submissions for devices that claim substantial equivalence to a predicate device, demonstrating safety and effectiveness through regulatory pathways. The UDI system tracks device identification data to improve tracking, tracing, and product safety. These registries ensure transparency and compliance with U.S. medical device regulations, particularly for Class I and Class II devices.
How are Bioness Inc.’s devices classified by the FDA, and what does that mean?
Bioness Inc.’s devices are classified under FDA categories Class I and Class II. Class I devices generally pose minimal risk and may be subject to general controls, such as good manufacturing practices. Class II devices involve a higher level of risk and require special controls, such as performance standards or post-market surveillance, to ensure safety and effectiveness. The classification determines the regulatory pathway and scrutiny each device undergoes before entering the market.
What kinds of devices does Bioness Inc. produce for pain management or rehabilitation?
Bioness Inc. manufactures several devices for pain management and rehabilitation, including analgesic PENS (Peripheral Nerve Stimulation) system probes for targeted pain relief, as well as transcutaneous electrical stimulation systems like the L300 Go System for lower-limb rehabilitation. Their portfolio also includes assistive training devices for perceptual-coordination support and hand orthoses, which help improve function and mobility in patients recovering from injuries or surgeries.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- bioness.com
- —
- —
- [email protected]
- Phone
- +1(800)211-9136
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 182287727
Catalogue (87)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| L300 Go System, Left Small Lower Leg | LG4-5V00 | FDA UDI | Class II | Active |
| NESS H200® Wireless Hand Rehabilitation System | H2W-5100 | FDA UDI | Class II | Active |
| L300 Go System | LG3-6800 | FDA UDI | Class II | Active |
| NESS H200® Wireless Hand Rehabilitation System | H2W-5000 | FDA UDI | Class II | Active |
| Bioness L300 Go Hydrogel Electrodes Set | LG3-5F00 | FDA UDI | Class II | Active |
| L300 Go System, Left Lower Leg | LG4-5100 | FDA UDI | Class II | Active |
| NESS L300-Plus System | L3P-5001 | FDA UDI | Class II | Unknown |
| NESS H200® Wireless Hand Rehabilitation System | H2W-5200 | FDA UDI | Class II | Active |
| L300 Go System | LG3-6700 | FDA UDI | Class II | Active |
| H200 Wireless System | H2W-5400 | FDA UDI | Class II | Active |
| NESS L300-Plus System | L3P-5100 | FDA UDI | Class II | Unknown |
| Bioness Integrated System (BITS)2.0.5 | 2.0.5 | FDA UDI | Class II | Active |
| BITS Motion Sensor | BITS-3355 | FDA UDI | Class II | Active |
| Bioness Integrated System (BITS) Bedside Configuration | BIT-2124 | FDA UDI | Class II | Active |
| NESS L300 Foot Drop System | LG3-5100 | FDA UDI | Class II | Unknown |
| Vector Elite | VEC-1000 | FDA UDI | Class I | Active |
| L300 Go System | LG3-6600 | FDA UDI | Class II | Active |
| NESS L300 Foot Drop System | LG3-4000 | FDA UDI | Class II | Unknown |
| L300 Go System | LG3-4V00 | FDA UDI | Class II | Active |
| L300 Go System | LG4-1000 | FDA UDI | Class II | Active |
| Bioness StimRouter Extended Hydrogel Electrode Set | ST2-7001 | EUDAMEDFDA UDI | Class II | Active |
| L300 Go System, Right Small Lower Leg | LG4-5U00 | FDA UDI | Class II | Active |
| H200 Wireless | H2W-SW01 | FDA UDI | Class II | Active |
| NESS L300 Foot Drop System | LG3-5000 | FDA UDI | Class II | Unknown |
| L300 Go System | SCE-1000 | FDA UDI | Class II | Active |
| NESS L300-Plus System | L3P-5101 | FDA UDI | Class II | Unknown |
| L300 Go System | L4P-5D00 | FDA UDI | Class II | Active |
| L360 Thigh System | L4T-6001 | FDA UDI | Class II | Active |
| Vector Base | VEC-3000 | FDA UDI | Class I | Active |
| StimRouter Implantable Kit | ST2-1000 | FDA UDI | Class II | Active |
| L300 Go System | L3P-5D00 | FDA UDI | Class II | Active |
| H200 Wireless System | H2W-4700 | FDA UDI | Class II | Active |
| H200 Wireless System | H2W-5000 | FDA UDI | Class II | Active |
| L100 Go System | LG1-5X00 | FDA UDI | Class II | Active |
| L300 Go Clinician Kit | LG4-4000 | FDA UDI | Class II | Active |
| H200 Wireless System | H2W-5200 | FDA UDI | Class II | Active |
| Bioness Integrated System (BITS)2.0.5 | 2.0.1 | FDA UDI | Class II | Active |
| NESS L300 Foot Drop System | LG3-5V00 | FDA UDI | Class II | Unknown |
| NESS H200® Wireless Hand Rehabilitation System | H2W-5500 | FDA UDI | Class II | Active |
| Bioness Integrated System (BITS)2.0.5 | BIT-2048 | FDA UDI | Class II | Active |
| H200 Wireless System | H2W-4100 | FDA UDI | Class II | Active |
| H200 Wireless System | H2W-5D00 | FDA UDI | Class II | Active |
| StimRouter | ST2-SW01 | FDA UDI | Class II | Active |
| Bioness Integrated System (BITS) Mobile Configuration | BIT-2224 | FDA UDI | Class II | Active |
| NESS H200® Wireless Hand Rehabilitation System | H2W-4100 | FDA UDI | Class II | Active |
| NESS H200® Wireless Hand Rehabilitation System | H2W-4000 | FDA UDI | Class II | Active |
| StimRouter User Kit | ST2-5000 | FDA UDI | Class II | Active |
| H200 Wireless System | H2W-5300 | FDA UDI | Class II | Active |
| L300 Go System, Right Lower Leg | LG4-5000 | FDA UDI | Class II | Active |
| NESS L300-Plus System | L3P-4100 | FDA UDI | Class II | Unknown |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.