Dynatron DX2 Traction Unit
FDA 510(k) K051680 · Dynatronics Corp.
510(k) numberK051680
Submission
- Device name
- Dynatron DX2 Traction Unit
- Applicant
- Dynatronics Corp.
Salt Lake City, UT, US - Received
- June 23, 2005
- Decision date
- October 11, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ILY – Lamp, Infrared, Therapeutic Heating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5500
- Specialty
- Physical Medicine
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Questions and answers
When was Dynatron DX2 Traction Unit cleared by the FDA?
Dynatron DX2 Traction Unit (K051680) received a 510(k) decision of Substantially Equivalent on October 11, 2005, 110 days after the submission was received.
What is the product code of K051680?
The FDA product code is ILY – Lamp, Infrared, Therapeutic Heating, a Class II (moderate risk) device regulated under 21 CFR 890.5500.