NK Grasp Sensor, Model GA002

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

510(k) Number

K923965 ↗

FDA Product Code

LBB

Device Class

Class II

Regulation

21 CFR Part 888.1240

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Nk Biotechnical Engineering Co. →

• What clinical scenarios is the NK Grasp Sensor, Model GA002, primarily used for in orthopedic evaluations?

  The NK Grasp Sensor, Model GA002, is designed to objectively measure grip strength and hand function, making it useful for assessing muscle performance in orthopedic evaluations. This includes monitoring recovery after injuries, surgeries (such as carpal tunnel release or tendon repairs), or conditions like arthritis, where grip strength may be compromised. It helps clinicians quantify hand function for treatment planning or progress tracking.

• Is the NK Grasp Sensor, Model GA002, intended for single-use or reusable applications, and how should it be maintained?

  The NK Grasp Sensor, Model GA002, is supplied as a reusable device and is non-sterile. Since it is not sterile, it should be cleaned and disinfected according to standard clinical equipment protocols after each use to ensure hygiene and longevity. Follow manufacturer guidelines for maintenance to prevent wear and ensure accurate measurements.

• Does the NK Grasp Sensor, Model GA002, require any special handling or safety considerations, such as MRI compatibility?

  No, the NK Grasp Sensor, Model GA002, does not have any MRI safety considerations listed in its documentation. However, as with all clinical dynamometers, it should be handled according to standard protocols for electrical medical devices, including proper grounding and routine inspections to ensure safe operation.

• What regulatory pathway was followed for FDA clearance of the NK Grasp Sensor, Model GA002, and what does this mean for its use?

  The NK Grasp Sensor, Model GA002, received FDA 510(k) clearance (K923965) under the Traditional 510(k) pathway, with a determination of Substantially Equivalent to a predicate device. This means the FDA reviewed it against existing dynamometers and confirmed it meets safety and effectiveness standards for measuring grip strength in clinical settings. The clearance is specific to orthopedic evaluations and does not imply broader indications.