Neu Platform Tremor Transducer
510(k) K250153
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK250153 | Date25 Apr 2025 | 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- Withdrawn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
- Full name
- Neu Platform
- 510(k) Number
- FDA Product Code
- GYD
- FDA applicant
- Neuhealth Digital , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1950
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Neu Platform Tremor Transducer is a Class II medical device classified under Transducer, Tremor (Regulation Number 882.1950). It is designed to measure and assess tremor activity in neurological patients, providing quantitative data for clinical evaluation and monitoring. This device aids in the assessment of movement disorders, particularly those related to Parkinson’s disease, essential tremor, or other conditions involving involuntary shaking. Its role is supported by regulatory categorisation under the Neurology specialty, ensuring alignment with clinical tremor diagnostics.
The Neu Platform Tremor Transducer is supplied as a reusable device, intended for use in clinical or home-based settings where tremor assessment is required. It operates under FDA 510K clearance (K250153) and is classified as a Class II device, adhering to regulatory standards for tremor measurement. The device is not specified as sterile or single-use, and no MRI safety classification is provided. Storage and handling instructions are not detailed in the regulatory submission, but compliance with manufacturer guidelines is implied for optimal performance and longevity.
Questions
AI-generated answers, 1 Oct 2026
What is the Neu Platform Tremor Transducer used for?
The Neu Platform Tremor Transducer is designed to measure and assess tremor activity in patients with neurological movement disorders. It provides quantitative data to aid clinicians in evaluating conditions like Parkinson’s disease, essential tremor, or other involuntary shaking disorders. The device aligns with regulatory standards for tremor diagnostics in neurology, ensuring reliable assessment for treatment planning or monitoring.
Is the Neu Platform Tremor Transducer reusable or single-use?
The Neu Platform Tremor Transducer is supplied as a reusable device. This design allows for repeated use in clinical or home-based settings where tremor assessment is required, provided proper cleaning and maintenance are followed as per manufacturer guidelines. Reusability helps reduce costs and waste while maintaining performance for ongoing patient monitoring.
Does the Neu Platform Tremor Transducer require sterilization before use?
The regulatory submission does not specify that the Neu Platform Tremor Transducer is sterile or requires sterilization before use. Since it is classified as reusable, standard cleaning protocols (as outlined by the manufacturer) are implied to ensure hygiene and functionality. Always follow the manufacturer’s instructions for preparation and maintenance.
What regulatory approval does the Neu Platform Tremor Transducer hold?
The Neu Platform Tremor Transducer holds FDA 510(k) clearance under the reference number K250153, classified as a Class II medical device. This clearance confirms it meets regulatory standards for tremor measurement and aligns with the intended use in neurology. The device is also categorized under the FDA’s Transducer, Tremor (Regulation Number 882.1950) classification.
Are there different models or sizes available for the Neu Platform Tremor Transducer?
The provided regulatory data does not specify multiple models or sizes for the Neu Platform Tremor Transducer. However, the device is designed for general tremor assessment in neurological patients, so compatibility with various patient needs may depend on manufacturer-specific configurations or accessories. For precise details, refer to the manufacturer’s product documentation or contact Neuhealth Digital, Ltd.