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TECAR Therapy Device (TC2000, TC2001) (K252288): 510(k) cleared for Shenzhen Dongdixin Technology Co., Ltd. vs Dynamis Pro Family (K252723): 510(k) cleared for Fotona D.O.O.: FDAPulse comparison
TECAR Therapy Device (TC2000, TC2001) (K252288): 510(k) cleared for Shenzhen Dongdixin Technology Co., Ltd.'s review days of 447 is 1.2x Dynamis Pro Family (K252723): 510(k) cleared for Fotona D.O.O.'s 387 (99th percentile). TECAR Therapy Device (TC2000, TC2001) (K252288): 510(k) cleared for Shenzhen Dongdixin Technology Co., Ltd. is dated 2026-10-13; Dynamis Pro Family (K252723): 510(k) cleared for Fotona D.O.O. 2026-09-19.
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe
How does TECAR Therapy Device (TC2000, TC2001) (K252288): 510(k) cleared for Shenzhen Dongdixin Technology Co., Ltd. compare to Dynamis Pro Family (K252723): 510(k) cleared for Fotona D.O.O.?
| Field | TECAR Therapy Device (TC2000, TC2001) (K252288): 510(k) cleared for Shenzhen Dongdixin Technology Co., Ltd. | Dynamis Pro Family (K252723): 510(k) cleared for Fotona D.O.O. |
|---|---|---|
| Record | 510(k) clearance | 510(k) clearance |
| 510(k) number | K252288 | K252723 |
| Device | TECAR Therapy Device (TC2000, TC2001) | Dynamis Pro Family |
| Applicant | Shenzhen Dongdixin Technology Co., Ltd. | Fotona D.O.O. |
| Specialty / panel | General, Plastic Surgery | General, Plastic Surgery |
| Product code | PBX | GEX |
| Device class | 2 | 2 |
| Clearance type | Traditional | Traditional |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Received | 2025-07-23 | 2025-08-28 |
| Decision date | 2026-10-13 | 2026-09-19 |
| Review time (days) | 447 | 387 |
| Third-party review | No | No |
| Applicant location | Shenzhen, CN | Ljubljana, SI |
| amount percentile | 99th | 99th |
| Predicate Speed & CAPA Advisory Opportunity Score | 61/100 | 55/100 |
| Peer rank and all 500 records (CSV) | 🔒 Click to unlock → | |
| Official source URLs for every peer record | 🔒 Click to unlock → | |
Official records: TECAR Therapy Device (TC2000, TC2001) (K252288): 510(k) cleared for Shenzhen Dongdixin Technology Co., Ltd. · Dynamis Pro Family (K252723): 510(k) cleared for Fotona D.O.O.
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