TECAR Therapy Device (TC2000)
by Shenzhen Dongdixin Technology Co., Ltd.
510(k) K252288
TECAR Therapy Device (TC2000) is a Class II device made by Shenzhen Dongdixin Technology Co., Ltd., cleared under FDA 510(k) K252288 on 13 Oct 2026, active as of 1 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK252288 | Date13 Oct 2026 | StatusActive |
Official records
- FDA 510(k) database K252288
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PBX
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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