510(k) K131899
K131899 is an FDA 510(k) premarket notification submitted by Shenzhen Dongdixin Technology Co., Ltd. for the device "SW-THERM". The FDA issued a decision of Substantially Equivalent on March 14, 2014. The device falls under product code IMJ (Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5290. Shenzhen Dongdixin Technology Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 2014
- Date Received
- June 25, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
- Device Class
- Class II
- Regulation Number
- 890.5290
- Review Panel
- PM
- Submission Type