Device class
—
Regulation —
Total clearances
4
2023-05-16 → 2025-07-18
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Excite Medical of Tampa Bay, LLC |
2 |
0 |
2025-07-18 |
|
Ergo-Flex Technologies, LLC |
1 |
0 |
2024-02-22 |
|
Zimmer Medizinsysteme GmbH
|
1 |
0 |
2023-05-16 |
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 |
| E0860 |
HCPCS
|
Traction equipment, overdoor, cervical ✓ CMS-verified description |
High
|
HCPCS code for motorized traction equipment |
| 97012 |
CPT
|
— |
Medium
|
CPT for mechanical traction therapeutic procedure |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-07-18 |
K243775 |
Excite Medical of Tampa Bay, LLC
|
True Non-Surgical Spinal Decompression System (DRX9000-SL) |
| 2025-06-18 |
K243366 |
Excite Medical of Tampa Bay, LLC
|
DRX9000C-SL Cervical Spinal Decompression System |
| 2024-02-22 |
K214037 |
Ergo-Flex Technologies, LLC
|
Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac |
| 2023-05-16 |
K222912 |
Zimmer Medizinsysteme GmbH
|
c1Trac |