Everyway Traction Unit, Model Ever-Trac ET-800
FDA 510(k) K112074 · Everyway Medical Instruments Co.,Ltd
510(k) numberK112074
Submission
- Device name
- Everyway Traction Unit, Model Ever-Trac ET-800
- Applicant
- Everyway Medical Instruments Co.,Ltd
Roswell, GA, US - Received
- July 20, 2011
- Decision date
- February 1, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ITH – Equipment, Traction, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5900
- Specialty
- Physical Medicine
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Questions and answers
When was Everyway Traction Unit, Model Ever-Trac ET-800 cleared by the FDA?
Everyway Traction Unit, Model Ever-Trac ET-800 (K112074) received a 510(k) decision of Substantially Equivalent on February 1, 2012, 196 days after the submission was received.
What is the product code of K112074?
The FDA product code is ITH – Equipment, Traction, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5900.