Device class
Class II
Regulation 882.5897
Total clearances
7
2021-10-05 → 2026-03-17
Definition
What is External Upper Limb Tremor Stimulator
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.
Classification details
Medical specialty
Neurology
Regulation number
882.5897
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Cala Health, Inc.
|
5 |
1 |
2026-03-17 |
|
Fasikl Incorporated |
1 |
0 |
2025-07-01 |
|
Encora, Inc. |
1 |
1 |
2026-02-05 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 64561 |
CPT
|
— |
Medium
|
CPT for percutaneous implantation of neurostimulator electrodes for tremor |
| 97014 |
CPT
|
— |
Medium
|
CPT for electrical stimulation for therapeutic purposes (external tremor treatment) |
Pulse
Most recent 510(k) clearances