Device class
—
Regulation —
Total clearances
7
2021-10-05 → 2026-03-17
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