Triton/Tru-Trac/Tx/Triton DTS Traction
FDA 510(k) K053223 · Chattanooga Group
510(k) numberK053223
Submission
- Device name
- Triton/Tru-Trac/Tx/Triton DTS Traction
- Applicant
- Chattanooga Group
Hixson, TN, US - Received
- November 17, 2005
- Decision date
- February 24, 2006
- 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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| K040285 | Vectra Transportable Combo and Stim (Specialty Line Dealers); Intelect Transportable…IMG · Traditional | 04/12/2004SE |
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Questions and answers
When was Triton/Tru-Trac/Tx/Triton DTS Traction cleared by the FDA?
Triton/Tru-Trac/Tx/Triton DTS Traction (K053223) received a 510(k) decision of Substantially Equivalent on February 24, 2006, 99 days after the submission was received.
What is the product code of K053223?
The FDA product code is ITH – Equipment, Traction, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5900.