Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rehabilicare, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022405 | MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE; PRO | Rehabilicare, Inc. | 2002-08-12 | 27 | 0 |
| K011017 | PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS D | Rehabilicare, Inc. | 2001-09-24 | 173 | 0 |
| K982410 | SMP-PLUS,SX-PLUS,SX MODEL # 49XX SERIES 9 VOLT TENS DEVICE | Rehabilicare, Inc. | 1998-11-06 | 116 | 0 |
| K971542 | ORTHO DX NEUROMUSCULAR STIMULATOR | Rehabilicare, Inc. | 1997-08-14 | 108 | 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