External Upper Limb Tremor Stimulator
The External Upper Limb Tremor Stimulator is a prescription device placed externally on the upper limb designed to provide symptom relief from tremors in the upper limb, used in the management of movement disorders such as essential tremor or Parkinson's disease-related tremor. It is classified as a Class 2 device under regulation 882.5897, requiring 510(k) premarket notification, and falls within the Neurology (NE) medical specialty. The product code is QBC. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QBC
- Device Class
- FDA class 2
- Regulation Number
- 882.5897
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K253587 | Cala kIQ Plus | Mar 17, 2026 | Substantially Equivalent | Cala Health, Inc. |
| K251517 | Encora X1 | Feb 05, 2026 | Substantially Equivalent | Encora, Inc. |
| K250096 | Felix NeuroAI System | Jul 01, 2025 | Substantially Equivalent | Fasikl Incorporated |
| K243848 | Cala kIQ | Jan 16, 2025 | Substantially Equivalent | Cala Health, Inc. |
| K242259 | Cala kIQ | Nov 22, 2024 | Substantially Equivalent | Cala Health, Inc. |
| K222237 | Cala kIQ | Nov 22, 2022 | Substantially Equivalent | Cala Health, Inc. |
| K203288 | Cala Trio | Oct 05, 2021 | Substantially Equivalent | Cala Health, Inc. |
| K182706 | External upper limb tremor stimulator | Oct 25, 2018 | Substantially Equivalent | Cala Health, Inc. |
| DEN170028 | Cala ONE | Apr 26, 2018 | Unknown | Cala Health, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.