Kneehab XP Controller, Model 411
FDA 510(k) K092791 · Bio-Medical Research, Ltd.
510(k) numberK092791
Submission
- Device name
- Kneehab XP Controller, Model 411
- Applicant
- Bio-Medical Research, Ltd.
Galway, IE - Received
- September 11, 2009
- Decision date
- December 30, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IPF – Stimulator, Muscle, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
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Questions and answers
When was Kneehab XP Controller, Model 411 cleared by the FDA?
Kneehab XP Controller, Model 411 (K092791) received a 510(k) decision of Substantially Equivalent on December 30, 2009, 110 days after the submission was received.
What is the product code of K092791?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.