VERI/DFS #817

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Veri/Dfs Tm #817

510(k) Number

K813515 ↗

FDA Product Code

GZI

Device Class

Class II

Regulation

21 CFR Part 882.5810

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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  Class II

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  Class II

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• Veri-Fier

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  Class II

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  Class II

  FDA 510(k) K791187 Active Cleared 22 Aug 1979

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• What types of clinical settings is the VERI/DFS #817 intended for use in, and how does its flexibility in use benefit patients?

  The VERI/DFS #817 is designed for clinical settings like physical therapy or rehabilitation centers, where it can be used for either single-use or reusable applications. Its flexibility allows clinicians to tailor neuromuscular stimulation to patients with disorders or mobility impairments, helping restore or maintain muscle activity as part of their treatment plan.

• Is the VERI/DFS #817 meant to be used repeatedly in a clinical setting, or is it intended for one-time use only?

  The device is explicitly labeled for single-use or reusable applications in clinical settings, meaning it can be used multiple times if properly cleaned and maintained—or disposed of after a single use, depending on facility protocols. This dual-use designation provides flexibility for different clinical workflows.

• What regulatory pathway was followed for the VERI/DFS #817, and how does this classification affect its use in neurology?

  The device was cleared via an FDA 510(k) submission (K813515) under the product code GZI, classified as Substantially Equivalent with a decision code of SESE. It falls under the Neurology advisory committee (NE) and is categorized as a Class II device, meaning it undergoes additional regulatory scrutiny to ensure safety and effectiveness in neuromuscular stimulation applications.

• Are there any specific storage requirements or considerations for the VERI/DFS #817 before first use or after cleaning?

  The provided data does not specify sterility or storage instructions for the VERI/DFS #817. If reused, it should follow standard clinical decontamination protocols (e.g., cleaning and sterilization) to prevent cross-contamination. For single-use units, adherence to manufacturer guidelines for handling and disposal is recommended to ensure patient safety.