# K143458: Neurosplint

- Pathway: 510(k) (Traditional)
- Applicant: Neurospectrum, LLC
- Decided: Aug 13, 2015 after 252 days
- Product code: IQI (Orthosis, Limb Brace)
- Device class: 1
- Regulation: 21 CFR 890.3475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
An orthosis worn on the wrist With rigid insert: to limit wrist motion while worn, allowing the body to recover from the damage of repetitive motion or other injuries to immobilize and / or support for functional improvement following, repetitive motion-type of injuries such as carpal tunnel syndrome (CTS), wrist strains or sprains, and similar injuries of the wrist Without rigid insert: to provide wrist support to provide temporary relief of associated symptoms of some repetitive motion wrist conditions to provide feedback to the user when the wrist reaches maximal flexion or extension

Source page: https://510kreport.com/device/K143458
Methodology: https://510kreport.com/methodology