Biorehab System
FDA 510(k) K011823 · Nicolet Biomedical, Inc.
510(k) numberK011823
Submission
- Device name
- Biorehab System
- Applicant
- Nicolet Biomedical, Inc.
Stoughton, WI, US - Received
- June 11, 2001
- Decision date
- September 6, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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| K111687 | Emg SystemHCC · Special | Myotronics-Noromed, Inc. | 09/29/2011SE |
| K092675 | GrindcareHCC · Traditional | Medotech A/S | 03/03/2010SE |
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| K011818 | Sterile Emg ElectrodesIKT · Abbreviated | 09/06/2001SE |
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Questions and answers
When was Biorehab System cleared by the FDA?
Biorehab System (K011823) received a 510(k) decision of Substantially Equivalent on September 6, 2001, 87 days after the submission was received.
What is the product code of K011823?
The FDA product code is HCC – Device, Biofeedback, a Class II (moderate risk) device regulated under 21 CFR 882.5050.