Bioness, Inc.
Valencia, CA, US
Bioness, Inc. appears in FDA device records in Valencia, CA. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Bioness, Inc. between 2011 and 2022. The busiest year on record is 2019, with 3. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2012 | 2 |
| 2013 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 3 |
| 2020 | 2 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K211965 | StimRouter Neuromodulation System | GZF | Substantially Equivalent | |
| K200482 | StimRouter Neuromodulation System | GZF | Substantially Equivalent | |
| K200262 | L100 Go System | GZI | Substantially Equivalent | |
| K190047 | StimRouter Neuromodulation System | GZF | Substantially Equivalent | |
| K191587 | L360 Thigh System | GZI | Substantially Equivalent | |
| K190285 | L300 Go System | GZI | Substantially Equivalent | |
| K173682 | L300 Go System | GZI | Substantially Equivalent | |
| K162407 | L300 Go System | GZI | Substantially Equivalent | |
| K142432 | StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit | GZF | Substantially Equivalent | |
| K123636 | H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE | GZI | Substantially Equivalent | |
| K122784 | NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT | GZI | Substantially Equivalent | |
| K120853 | NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, | GZI | Substantially Equivalent | |
| K103343 | L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT) | GZI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain