Maxems, Models 1000 and 2000
FDA 510(k) K091248 · Bio Protech, Inc.
510(k) numberK091248
Submission
- Device name
- Maxems, Models 1000 and 2000
- Applicant
- Bio Protech, Inc.
Dallas, TX, US - Received
- April 28, 2009
- Decision date
- November 30, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K100246 | MAX-IF1000LIH · Traditional | 11/24/2010SE |
| K092732 | Propencil Esu PencilGEI · Traditional | 11/25/2009SE |
| K092761 | Proplate, Models 9641C, 9641F, P9641C, P9641F, 9642C, 9642F and P9642CGEI · Special | 11/24/2009SE |
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Questions and answers
When was Maxems, Models 1000 and 2000 cleared by the FDA?
Maxems, Models 1000 and 2000 (K091248) received a 510(k) decision of Substantially Equivalent on November 30, 2009, 216 days after the submission was received.
What is the product code of K091248?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.