Device class
Class II
Regulation 890.5525
Total clearances
4
2020-02-10 → 2025-04-01
Classification details
Medical specialty
Physical Medicine
Regulation number
890.5525
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Taiwan Medical Electronics Co., Ltd. |
1 |
0 |
2025-04-01 |
|
Top-Rank Health Care Co., Ltd.
|
1 |
0 |
2023-10-16 |
|
Dermadry Laboratories, Inc. |
1 |
0 |
2020-02-10 |
|
Hidroxa Medical AB |
1 |
0 |
2024-10-17 |
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 |
| 97012 |
CPT
|
— |
Medium
|
Alternative modality code depending on therapeutic context and payer policies |
| 97014 |
CPT
|
— |
Medium
|
Iontophoresis application in physical medicine, standard modality code |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-04-01 |
K242041 |
Taiwan Medical Electronics Co., Ltd.
|
STOPWET iontophoresis apparatus (SW01) |
| 2024-10-17 |
K241267 |
Hidroxa Medical AB
|
Hidroxa SE30 |
| 2023-10-16 |
K232020 |
Top-Rank Health Care Co., Ltd.
|
Iontophoresis Electrodes |
| 2020-02-10 |
K192749 |
Dermadry Laboratories, Inc.
|
Dermadry |