510(k) K243848

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

January 16, 2025

Date Received

December 16, 2024

Clearance Type

Special

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

External Upper Limb Tremor Stimulator

Device Class

Class II

Regulation Number

882.5897

Review Panel

NE

Submission Type

An external upper limb tremor stimulator is a prescription device which is placed externally on the upper limb and designed to aid in tremor symptom relief of the upper limb.