510(k) · Cleared
ClearedNess System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ness-Neuromuscular Electrical Stimulation Systems · IPF Stimulator, Muscle, Powered
Cleared on Sep 11, 2002 as substantially equivalent to K952273 (Neuromusclar Electrical Stimulation Systems, Ltd., 1996) and 1 other predicate after a 21-day review. Its family tree reaches back 3 generations to 1981. 17 later devices descend from it.
- Decided
- Sep 11, 2002
- Review
- 21 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K813008 (1981). 5 ancestors in all. 17 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK813008 Respond II...Neuromuscular StimulatorMedtronic Vascular · 1981
- 2 generations backK952273 Handmaster NMS1Neuromusclar Electrical Stimulation Systems, Ltd. · 1996
- 1 generation backK982482 Handmaster NMS1N.E.S.S. Nuromuscular Electrical Stimulation Syst · 1998
- This deviceK022776 Ness SystemNess-Neuromuscular Electrical Stimulation Systems · 2002
- Descendant · cites it directly · 15 of its ownK103343 L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right…Bioness, Inc. · 2011
- Descendant · 2 generations on · 14 of its ownK123972 Walkaide SystemInnovative Neurotronics, Inc. · 2013
- Descendant · 3 generations on · 10 of its ownK140886 Walkaide SystemInnovative Neurotronics, Inc. · 2014
- Descendant · 2 generations on · 9 of its ownK162407 L300 Go SystemBioness, Inc. · 2017
- Descendant · 3 generations on · 7 of its ownK173682 L300 Go SystemBioness, Inc. · 2018
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K103343L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left)Bioness, Inc. · 2011 · cites it directly15descendants
- K123972Walkaide SystemInnovative Neurotronics, Inc. · 2013 · 2 generations on14descendants
- K140886Walkaide SystemInnovative Neurotronics, Inc. · 2014 · 3 generations on10descendants
- K162407L300 Go SystemBioness, Inc. · 2017 · 2 generations on9descendants
- K173682L300 Go SystemBioness, Inc. · 2018 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K813008 | Respond II...Neuromuscular Stimulator | Medtronic Vascular | 1981 | — |
| −2 | K952273 | Handmaster NMS1 | Neuromusclar Electrical Stimulation Systems, Ltd. | 1996 | — |
| −1 | K982482 | Handmaster NMS1 | N.E.S.S. Nuromuscular Electrical Stimulation Syst | 1998 | — |
| 0 (this device) | K022776 | Ness System | Ness-Neuromuscular Electrical Stimulation Systems | 2002 | — |
| +1 | K103343 | L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left) | Bioness, Inc. | 2011 | — |
| +2 | K123972 | Walkaide System | Innovative Neurotronics, Inc. | 2013 | — |
| +3 | K140886 | Walkaide System | Innovative Neurotronics, Inc. | 2014 | — |
| +2 | K162407 | L300 Go System | Bioness, Inc. | 2017 | — |
| +3 | K173682 | L300 Go System | Bioness, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 IPF? 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 IPF device
- #1 K241433 EVE Synergy (EVE-20M)score 19.6 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K952273 | Handmaster NMS1Summary page 2…7-3 \\\PH.64270/0001 . 10753 VI Predicate Device: N.E.S.S. Neuromuscular Electrical Stimulation Systems Handmaster NMS 1 (K952273, and K982482). Intended Use: The NESS System is intended to be used for the following indications: maintenance or increa… | 1996 |
| * | K982482 | Handmaster NMS1Summary page 2…7-3 \\\PH.64270/0001 . 10753 VI Predicate Device: N.E.S.S. Neuromuscular Electrical Stimulation Systems Handmaster NMS 1 (K952273, and K982482). Intended Use: The NESS System is intended to be used for the following indications: maintenance or increase of range o… | 1998 |
What descends from it? (17)
See all 172 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K103343 (Bioness, Inc., 2011) has gone furthest, with 15 descendants of its own.
- 3 other devices also cite its predicate K952273.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IPF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPF
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IPF
8in 2025
MAUDE reports naming product code IPF, 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 | 8 | 143 | 0 | 11 |
| 2008 | 6 | 140 | 1 | 213 |
| 2009 | 7 | 216 | 0 | 150 |
| 2010 | 4 | 121 | 0 | 14 |
| 2011 | 4 | 275 | 1 | 25 |
| 2012 | 4 | 269 | 3 | 16 |
| 2013 | 10 | 180 | 0 | 6 |
| 2014 | 4 | 264 | 0 | 19 |
| 2015 | 3 | 43 | 0 | 11 |
| 2016 | 7 | 113 | 0 | 8 |
| 2017 | 5 | 110 | 0 | 2 |
| 2018 | 5 | 73 | 0 | 3 |
| 2019 | 4 | 133 | 0 | 10 |
| 2020 | 9 | 121 | 0 | 13 |
| 2021 | 15 | 98 | 0 | 3 |
| 2022 | 7 | 108 | 0 | 4 |
| 2023 | 9 | 255 | 1 | 8 |
| 2024 | 7 | 201 | 0 | 5 |
| 2025 | 3 | 257 | 0 | 8 |
| 2026 | 3 | 206 | 0 | — |
What is it indicated for?
The NESS System is intended to be used for the following indications:
maintenance or increase of range of motion,
reduction of muscle spasm,
prevention or retardation of disuse atrophy,
muscle reeducation, and
increasing local blood circulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022776 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022776: Ness System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022776
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026