(252 days)
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
An orthosis worn on the wrist
I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter for a device called "Neurosplint," outlining its indications for use and regulatory information. It does not include details about device performance metrics, study designs, sample sizes, or expert involvement as requested.
§ 890.3475 Limb orthosis.
(a)
Identification. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.