510(k) · Cleared
ClearedBiorehab System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nicolet Biomedical, Inc. · HCC Device, Biofeedback
Cleared on Sep 6, 2001 as substantially equivalent to K960508 (The Prometheus Group, 1997) and 2 other predicates after an 87-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Sep 6, 2001
- Review
- 87 days
- Class
- Class II
- Product code
- HCC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K854277 (1986). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK854277 Neuropath 4000Therapeutic Technologies, Inc. · 1986
- This deviceK011823 Biorehab SystemNicolet Biomedical, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854277 | Neuropath 4000 | Therapeutic Technologies, Inc. | 1986 | — |
| 0 (this device) | K011823 | Biorehab System | Nicolet Biomedical, Inc. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HCC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HCC device
- #1 K233580 A Breathing System (ABS)score 8.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K960508 | Pathway Electromyograph Model Pathway II/MR-10/MR-15/MR-20/MR-25Summary page 1…oduct Code: HCC 510(k) Number: Manufacture: Trade Name: 510(k) Number: Manufacture: Trade Name: 510(k) Number: Manufacture: Trade Name: 1.0 Description of Device K960508 The Prometheus Group Pathway II Perineometer, MR Series of Amplifiers K935853 Product Code: HCC UniTech Research Inc. EMG Train… | 1997 |
| * | K935853 | Emg TrainerSummary page 1…cture: Trade Name: 510(k) Number: Manufacture: Trade Name: 1.0 Description of Device K960508 The Prometheus Group Pathway II Perineometer, MR Series of Amplifiers K935853 Product Code: HCC UniTech Research Inc. EMG Trainer K854277 Product Code: HCC Therapeutic Alliance Inc. NeuroEducator The BioR… | 1995 |
| * | K854277 | Neuropath 4000Summary page 1…1.0 Description of Device K960508 The Prometheus Group Pathway II Perineometer, MR Series of Amplifiers K935853 Product Code: HCC UniTech Research Inc. EMG Trainer K854277 Product Code: HCC Therapeutic Alliance Inc. NeuroEducator The BioRehab System consists of an EMG amplifier, computer and softwa… | 1986 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
How does its category compare?
All HCC devicesHCC Device, Biofeedback: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HCC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HCC
Too few HCC 510(k)s in any year since 2007 to give a median.
Recalls per year · HCC
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HCC
5in 2024
MAUDE reports naming product code HCC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 2 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BioRehab System is used for electromyography (EMG) biofeedback support of relaxation and muscle reeducation. The BioRehab System may be used by licensed medical practitioners to support their methods of muscle relaxation and reeducation/rehabilitation. The BioRehab System can be used in hospital, physician office, clinics, long-term patient care facilities, home and other therapy locations.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011823 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011823: Biorehab System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011823
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026