Freehand System

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Neurocontrol Freehand System

Trade Name

Neurocontrol Freehand System(R)

Generic Name

Stimulator, neuromuscular, implanted

PMA Number

P950035 ↗

FDA Product Code

GZC

Device Class

Class III

Regulation

21 CFR Part 882.5860

Advisory Committee

Physical Medicine

FDA Decision

APPR Approved

• Theraport Low-Profile Vascular Access System Models 1011 and 1012

  Class II

  FDA 510(k) K974475 Active Cleared 2 Mar 1998

• Theraport Vascular Access System; Model 1001, 1002, 1601, 1602

  Class II

  FDA 510(k) K960350 Active Cleared 15 Apr 1996

• What specific neurological conditions does the Freehand System address, and how does it restore function?

  The Freehand System is designed for skeletally mature patients with tetraplegia caused by C5 or C6 spinal cord injuries (per ASIA Classification). It functions as an upper extremity neuroprosthesis by electrically stimulating forearm and hand muscles via an implanted receiver-stimulator (Model 202-1) and epimysial electrodes (Model 203-1), enabling patients to regain functional grasp, hold, and release of objects. This is achieved through targeted neuromuscular stimulation to restore motor control in paralyzed limbs.

• Is the Freehand System intended for single-use or reusable components, and how is it supplied?

  The Freehand System includes both implantable (single-use) and external (reusable) components. The implantable parts—such as the receiver-stimulator (Model 202-1) and electrode set (Model 203-1)—are designed for permanent implantation and are not intended for reuse. The external patient system (Model 204-1) and programming system (Model 209-1) are reusable and supplied as part of the complete system for patient use and clinician programming, respectively.

• What are the key requirements for a patient to be eligible for the Freehand System?

  Eligibility is limited to skeletally mature patients with tetraplegia due to C5 or C6 spinal cord injuries (ASIA Classification), who have adequate upper extremity range of motion and intact lower motor neuron innervation of the forearm and hand musculature. These criteria ensure the system can effectively stimulate target muscles to restore functional grasp and release.

• How is the Freehand System regulated, and what does its approval status mean for clinicians?

  The Freehand System received FDA Premarket Approval (PMA) under PMA number P950035, confirming it meets rigorous safety and effectiveness standards for its intended use as an implanted neuromuscular stimulator. This approval ensures clinicians can rely on its clinical evidence and design for restoring upper extremity function in eligible patients, though individual patient selection must still align with the specified indications.