Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ness-Neuromuscular Electrical Stimulation Systems — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
206 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K111767 | NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND C | Ness-Neuromuscular Electrical Stimulation Systems | 2011-09-15 | 84 | 0 |
| K080219 | MODIFICATION TO:NESS L300 | Ness-Neuromuscular Electrical Stimulation Systems | 2008-02-28 | 30 | 0 |
| K053468 | NESS L300 | Ness-Neuromuscular Electrical Stimulation Systems | 2006-07-07 | 206 | 0 |
| K031900 | HANDMASTER | Ness-Neuromuscular Electrical Stimulation Systems | 2003-08-08 | 50 | 0 |
| K024279 | NESS CHILDREN SYSTEM | Ness-Neuromuscular Electrical Stimulation Systems | 2003-02-05 | 44 | 0 |
| K022776 | NESS SYSTEM | Ness-Neuromuscular Electrical Stimulation Systems | 2002-09-11 | 21 | 0 |
| K012823 | MODIFICATION TO HANDMASTER | Ness-Neuromuscular Electrical Stimulation Systems | 2001-11-14 | 90 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda