Akron ATP9 Traction Machine
FDA 510(k) K992733 · Huntleigh Technology, Inc.
510(k) numberK992733
Submission
- Device name
- Akron ATP9 Traction Machine
- Applicant
- Huntleigh Technology, Inc.
Manalapan, NJ, US - Received
- August 13, 1999
- Decision date
- November 10, 1999
- 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 Akron ATP9 Traction Machine cleared by the FDA?
Akron ATP9 Traction Machine (K992733) received a 510(k) decision of Substantially Equivalent on November 10, 1999, 89 days after the submission was received.
What is the product code of K992733?
The FDA product code is ITH – Equipment, Traction, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5900.