Device class
Class II
Regulation 870.5225
Total clearances
3
2020-08-05 → 2025-12-22
Classification details
Medical specialty
Cardiovascular
Regulation number
870.5225
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Vamed Medical Instrument Co., Ltd. |
1 |
0 |
2020-08-28 |
|
Pression, Inc. |
1 |
1 |
2025-12-22 |
|
Omay(Guangzhou)Med Technologies Co., Ltd. |
1 |
0 |
2020-08-05 |
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 |
| 92971 |
CPT
|
— |
Medium
|
CPT 92971 for percutaneous peripheral intra-aortic balloon assist device; including counterpulsation |
| 92973 |
CPT
|
— |
Medium
|
Alternative code for counterpulsation therapy management |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-12-22 |
K250756 |
Pression, Inc.
|
Pression Wave PRO External Counter-Pulsation System |
| 2020-08-28 |
K202108 |
Vamed Medical Instrument Co., Ltd.
|
External Counterpulsation System, Soulaire |
| 2020-08-05 |
K191955 |
Omay(Guangzhou)Med Technologies Co., Ltd.
|
Enhanced External Counter Pulsation Device Plus Omay-A |