Question 1

What types of medical devices does Bioness Inc. manufacture?

Accepted Answer

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.

Question 2

Where is Bioness Inc. based, and how does that affect its regulatory oversight?

Accepted Answer

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.

Question 3

Which regulatory registries list Bioness Inc.’s devices, and why?

Accepted Answer

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.

Question 4

How are Bioness Inc.’s devices classified by the FDA, and what does that mean?

Accepted Answer

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.

Question 5

What kinds of devices does Bioness Inc. produce for pain management or rehabilitation?

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
L300 Go Clinician Programmer Software	LG4-SW01	FDA UDI	Class II	Active
L360 Thigh System	L4T-6000	FDA UDI	Class II	Active
NESS H200® Wireless Hand Rehabilitation System	H2W-5400	FDA UDI	Class II	Active
StimRouter Clinician's Kit	ST2-4000	FDA UDI	Class II	Active
H200 Wireless System	H2W-4000	FDA UDI	Class II	Active
L100 Go System	LG1-5Y00	FDA UDI	Class II	Active
L300 Go System	L4T-5000	FDA UDI	Class II	Active
Bioness Integrated Therapy System, BITS 3.0, BITS Balance	BITS-3155	FDA UDI	Class II	Active
L300 Go System	SCE-1100	FDA UDI	Class II	Active
H200 Wireless System	H2W-5100	FDA UDI	Class II	Active
StimRouter User Kit	ST2-5050	FDA UDI	Class II	Active
Vector Elite	VEC-1100	FDA UDI	Class I	Active
NESS H200® Wireless Hand Rehabilitation System	H2W-4700	FDA UDI	Class II	Active
NESS H200® Wireless Hand Rehabilitation System	H2W-5300	FDA UDI	Class II	Active
L300 Go System	LG3-6900	FDA UDI	Class II	Active
H200 Wireless System	H2W-5500	FDA UDI	Class II	Active
NESS L300 Foot Drop System	LG3-5U00	FDA UDI	Class II	Unknown
L300 Go System	LG4-1100	FDA UDI	Class II	Active
L300 Go System, Right Thigh Plus	L4P-5100	FDA UDI	Class II	Active
Bioness Integrated System (BITS)2.0.5	BIT-2055	FDA UDI	Class II	Active
Bioness Integrated Therapy System, BITS 3.0, BITS Balance	BITS-3055	FDA UDI	Class II	Active
L300 Go System, Left Thigh Stand-Alone	L4T-5001	FDA UDI	Class II	Active
NESS L300-Plus System	L3P-5000	FDA UDI	Class II	Unknown
L300 Go System, Left Thigh Plus	L4P-5001	FDA UDI	Class II	Active
L300 Go System	K190285	FDA 510(k)	Class II	Active
Ness L300 System Kit, Left, Ness L300 System Kit, Right, Small Ness L300 System Kit, Right, Small Ness L300 System Kit,	K120853	FDA 510(k)	Class II	Active
StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit	K142432	FDA 510(k)	Class II	Active
L100 Go System	K200262	FDA 510(k)	Class II	Active
StimRouter Neuromodulation System	K190047	FDA 510(k)	Class II	Active
StimRouter Neuromodulation System	K211965	FDA 510(k)	Class II	Active
L300 Plus System (right, Left), L300 Plus System Upgrade Kit (right, Left)	K103343	FDA 510(k)	Class II	Active
H200 Wireless Hand Rehabilitation System With Optional Intelli-Connect Earpiece Triggering Device	K123636	FDA 510(k)	Class II	Active
Ness L300 System Kit, Lef Model Lg3-5100; Ness L300 System Kit, Right Model Lg3-5000; Small Ness L300 System Kit, Right	K122784	FDA 510(k)	Class II	Active
L300 Go System	K173682	FDA 510(k)	Class II	Active
StimRouter Neuromodulation System	K200482	FDA 510(k)	Class II	Active
L300 Go System	K162407	FDA 510(k)	Class II	Active
L360 Thigh System	K191587	FDA 510(k)	Class II	Active

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