ZapStim Controller Application Z1023
510(k) K233631
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK233631 | Date9 Feb 2024 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- OBP
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5805
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The ZapStim Controller Application Z1023 is a software-as-a-medical-device (SaMD) designed to interface with transcranial magnetic stimulator (TMS) hardware. It functions as a control application for selecting and executing treatment protocols, including parameters such as frequency, train length, and intertrain intervals. By managing these settings, it enables precise modulation of stimulation parameters for therapeutic or diagnostic purposes in neurology applications. The device operates as an adjunct to an existing TMS system, coordinating stimulation sequences without delivering the actual magnetic pulses.
The application is supplied as software installed on a commercial off-the-shelf PC and is intended for use in clinical settings where TMS therapy is administered. It is classified as a Class 2 device under FDA regulations (product code OBP) and has received FDA 510(k) clearance through the Traditional pathway. The device is not sterile or single-use; it is reusable and intended for repeated use in controlled environments. No specific MRI safety or sterility requirements are noted in the regulatory data, and its use is governed by the authorized TMS system’s operational guidelines. Clearance was granted under the advisory committee for Neurology (NE) and is associated with the predicate device’s hardware control functions.
Questions
AI-generated answers, 1 Oct 2026
What is the ZapStim Controller Application Z1023 used for?
The ZapStim Controller Application Z1023 is a software-as-a-medical-device designed to interface with transcranial magnetic stimulator (TMS) hardware. It enables clinicians to select and execute treatment protocols by adjusting parameters like frequency, train length, and intertrain intervals. This precise modulation of stimulation settings supports therapeutic or diagnostic purposes in neurology, functioning as an adjunct to an existing TMS system without delivering the magnetic pulses itself.
How is the ZapStim Controller Application Z1023 supplied and where is it used?
The application is supplied as software installed on a commercial off-the-shelf (COTS) PC. It is intended exclusively for use in clinical settings where TMS therapy is administered, allowing for controlled and repeatable stimulation protocols in neurology applications.
Is the ZapStim Controller Application Z1023 sterile or single-use?
No, the ZapStim Controller Application Z1023 is not sterile and is designed for reusable, repeated use in controlled clinical environments. Since it operates as software on a PC, sterility is not applicable, and it is not intended for single-use disposal.
What regulatory pathway was followed for FDA clearance of the ZapStim Controller Application Z1023?
The ZapStim Controller Application Z1023 received FDA 510(k) clearance through the Traditional pathway. It is classified as a Class 2 device under FDA regulations (product code OBP) and was reviewed by the Neurology (NE) advisory committee. Clearance was granted based on substantial equivalence to a predicate device’s hardware control functions.
Does the ZapStim Controller Application Z1023 have any specific MRI safety or sterility requirements?
The regulatory data for the ZapStim Controller Application Z1023 does not specify any MRI safety requirements or sterility mandates. Its use is governed by the operational guidelines of the authorized TMS system it interfaces with, and it is intended for non-MRI environments where TMS therapy is administered.