ITJFDA Class 1 · 21 CFR 890.3825
Walker, Mechanical
Device family · Physical Medicine
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
14
Manufacturers
4
Flagged signals
29
Adverse-event reports
4,178
Code matrix
| FDA product code | ITJ |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3825 |
| GMDN | — (crosswalk pending) |
| Implantable | No |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| 2014 | 23 | 2329.1 | 50,454 | |
| 2013 | 3 | 2256.5 | 4,687 | |
| 2013 | 22 | 2226.3 | 46,067 | |
| 2014 | 18 | 1644.3 | 27,613 | |
| 2013 | 14 | 1033.5 | 13,305 | |
| 2014 | 14 | 1033.5 | 13,305 | |
| 2014 | 14 | 1012.7 | 13,037 | |
| 2013 | 13 | 939.7 | 11,175 | |
| 2013 | 10 | 908.7 | 8,129 | |
| 2011 | 8 | 576.4 | 4,017 | |
| 2014 | 22 | 446.5 | 9,205 | |
| 2012 | 6 | 440.6 | 2,202 | |
| 2013 | 6 | 431.7 | 2,157 | |
| 2011 | 5 | 366.9 | 1,472 | |
| 2013 | 18 | 364.4 | 6,092 | |
| 2012 | 4 | 287.4 | 871 | |
| 2012 | 3 | 219.9 | 452 | |
| 2012 | 3 | 215.4 | 443 | |
| 2012 | 6 | 120.5 | 594 | |
| Other | 2011 | 8 | 113.2 | 782 |
| 2010 | 3 | 60.1 | 120 | |
| Other | 2012 | 18 | 30.8 | 490 |
| Other | 2011 | 9 | 15.4 | 107 |
| Other | 2011 | 4 | 13.4 | 34 |
| Other | 2010 | 7 | 12.0 | 60 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 1 family · 4,178 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Maddak, Inc. | 2 | 1979 | — |
| Kaye Products, Inc. | 1 | 1983 | — |
| CONVAID PRODUCTS, INC. | 1 | 1983 | — |
| Fred Sammons, Inc. | 1 | 1981 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
CHILD'S WALKER · Kaye Products, Inc.510(k) · 1983-11-29
UMBRELLA WALKER · Convaid Products, Inc.510(k) · 1983-10-27
WALK N ROLL · Meta-Morris510(k) · 1983-05-25
RESI-WALKER · Lic-Orthion510(k) · 1983-04-05
RESI-WALKER · Orthion Corp.510(k) · 1982-11-05
LIGHT WEIGHT ALUMINUM WALKER · Manuco Manufacturing Co., Inc.510(k) · 1982-05-21
WALK-A-CYCLE · Walk-A-Cycle Division510(k) · 1982-04-08
WALKER/CRUTCH BAG · Fred Sammons, Inc.510(k) · 1981-06-16
DELTA ROLLING SELF-LICKING WALKER · Staricat, Inc.510(k) · 1979-10-30
WALKING AID · Maddak, Inc.510(k) · 1979-04-03
WALKING AID · Guardian Products Co., Inc.510(k) · 1977-11-11
ANIMATOR · Kdk Medical Products510(k) · 1977-04-15
WALKING AID · Will Ross Co.510(k) · 1977-04-08
MANOY WALKING AID · Maddak, Inc.510(k) · 1977-01-28
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.