510(k) K252288
K252288 is an FDA 510(k) premarket notification submitted by Shenzhen Dongdixin Technology Co., Ltd. for the device "TECAR Therapy Device (TC2000, TC2001)". The FDA issued a decision of Substantially Equivalent on Oct 13, 2026. The device falls under product code PBX (Massager, Vacuum, Radio Frequency Induced Heat), a Class II device regulated under 21 CFR 878.4400. Shenzhen Dongdixin Technology Co., Ltd. has 26 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 13, 2026
- Date Received
- Jul 23, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Massager, Vacuum, Radio Frequency Induced Heat
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type
- 510(k)
Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.