Dynatron STS RX
FDA 510(k) K010948 · Dynatronics Corp.
510(k) numberK010948
Submission
- Device name
- Dynatron STS RX
- Applicant
- Dynatronics Corp.
Salt Lake City, UT, US - Received
- March 29, 2001
- Decision date
- May 15, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Dynatron STS RX cleared by the FDA?
Dynatron STS RX (K010948) received a 510(k) decision of Substantially Equivalent on May 15, 2001, 47 days after the submission was received.
What is the product code of K010948?
The FDA product code is LIH – Interferential Current Therapy, a Class II (moderate risk) device regulated under 21 CFR 882.5890.