Device class
—
Regulation —
Total clearances
4
2020-12-25 → 2025-02-15
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Impact Applications, Inc. |
2 |
0 |
2023-09-16 |
|
Sway Medical, Inc. |
1 |
0 |
2025-02-15 |
|
Vista Lifesciences, Inc. |
1 |
0 |
2021-03-25 |
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 |
| 96160 |
CPT
|
— |
Medium
|
Psychometric testing by physician/qualified health care professional |
| 99213 |
CPT
|
— |
Low
|
Office visit, established patient, moderate complexity |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-02-15 |
K241737 |
Sway Medical, Inc.
|
Sway System Sports Plus |
| 2023-09-16 |
K231688 |
Impact Applications, Inc.
|
ImPACT Version 4 |
| 2021-03-25 |
K201376 |
Vista Lifesciences, Inc.
|
ANAM Test System |
| 2020-12-25 |
K202485 |
Impact Applications, Inc.
|
ImPACT Version 4 |