Device class
Class II
Regulation 870.3600
Total clearances
3
2020-05-13 → 2025-01-10
Classification details
Medical specialty
Cardiovascular
Regulation number
870.3600
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Solo Pace, Inc. |
1 |
0 |
2025-01-10 |
|
Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. |
1 |
0 |
2024-01-07 |
|
Medtronic, Inc.
|
1 |
0 |
2020-05-13 |
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 |
| 93000 |
CPT
|
— |
Medium
|
Cardiac monitoring with external pacemaker pulse generator |
| 93042 |
CPT
|
— |
Medium
|
Rhythm strip interpretation with external pacing |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-01-10 |
K241781 |
Solo Pace, Inc.
|
Solo Pace Control |
| 2024-01-07 |
K232721 |
Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.
|
Lifetech Cardio Temporary Pacemaker |
| 2020-05-13 |
K201011 |
Medtronic, Inc.
|
Medtronic Model 5392 External Pulse Generator (EPG) |