Sw-Therm
FDA 510(k) K131899 · Shenzhen Dongdixin Technology Co., Ltd.
510(k) numberK131899
Submission
- Device name
- Sw-Therm
- Applicant
- Shenzhen Dongdixin Technology Co., Ltd.
Shenzhen, CN - Received
- June 25, 2013
- Decision date
- March 14, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- IMJ – Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5290
- Specialty
- Physical Medicine
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Questions and answers
When was Sw-Therm cleared by the FDA?
Sw-Therm (K131899) received a 510(k) decision of Substantially Equivalent on March 14, 2014, 262 days after the submission was received.
What is the product code of K131899?
The FDA product code is IMJ – Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat, a Class II (moderate risk) device regulated under 21 CFR 890.5290.