FSAFDA Class 1 · 21 CFR 880.5510
Lift, Patient, Non-Ac-Powered
Device family · General Hospital
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
13
Manufacturers
3
Flagged signals
28
Adverse-event reports
10,196
Code matrix
| FDA product code | FSA |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5510 |
| 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 |
|---|---|---|---|---|
| 2012 | 3 | 1864.1 | 3,871 | |
| 2013 | 3 | 1864.1 | 3,871 | |
| Other | 2011 | 7 | 172.4 | 1,029 |
| Other | 2013 | 5 | 123.2 | 490 |
| Other | 2010 | 4 | 98.5 | 295 |
| Other | 2010 | 18 | 66.2 | 1,092 |
| Other | 2010 | 7 | 40.5 | 232 |
| Other | 2011 | 8 | 29.4 | 192 |
| Other | 2011 | 5 | 28.9 | 108 |
| Other | 2010 | 25 | 24.5 | 542 |
| Other | 2012 | 5 | 18.4 | 66 |
| Other | 2011 | 13 | 12.8 | 129 |
| Other | 2010 | 3 | 11.0 | 18 |
| Other | 2014 | 9 | 9.0 | 56 |
| Other | 2010 | 5 | 8.9 | 28 |
| Other | 2011 | 4 | 7.1 | 15 |
| Death | 2017 | 3 | 6.7 | 9 |
| Death | 2025 | 3 | 6.7 | 9 |
| Death | 2010 | 3 | 6.4 | 9 |
| Other | 2014 | 3 | 5.3 | 7 |
| Other | 2012 | 3 | 5.3 | 7 |
| Other | 2013 | 13 | 5.2 | 40 |
| Other | 2013 | 4 | 4.0 | 6 |
| Other | 2012 | 10 | 4.0 | 19 |
| Death | 2011 | 4 | 3.9 | 6 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 1 family · 10,196 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Orthopedic Equipment Co., Inc. | 1 | 1978 | — |
| Invacare Corp. | 1 | 1984 | — |
| SURGIN SURGICAL INSTRUMENTATION, INC. | 1 | 1994 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
SURGICAL LIFT SHEET · Surgin Surgical Instrumentation, Inc.510(k) · 1994-08-02
SANITAS PATIENT LIFT · Dutton-Lainson Co.510(k) · 1993-09-13
ANOLIFT - PORTABLE & ANOLIFT - GANTRY · Anodyne Corp.510(k) · 1990-09-12
HOYER ONE-TOUCH POWER LIFTER · Ted Hoyer & Co., Inc.510(k) · 1986-03-27
MOLIFT · Madshus A/S510(k) · 1985-05-17
MEDI-MAN WATER POWERED BATH LIFT & HYDRAULIC LIFT · Medi-Man Rehabilitation Products, Inc.510(k) · 1985-04-01
SHOWER TROLLEY · Setma, Inc.510(k) · 1984-05-07
VARIABLE HEIGHT TRANSFER CHAIR · Setma, Inc.510(k) · 1984-05-07
BATTERY POWERED PATIENT LIFT · Invacare Corp.510(k) · 1984-04-17
MARTIN PELVIC LIFT · Martin Pelvic Lift Co.510(k) · 1983-04-28
CENTURY LIFT TRANSFER SYSTEM · Century Manufacturing Co.510(k) · 1981-07-23
LIFELIFT MODELS ONE AND TWO · Corda Int'L Holiday, Inc.510(k) · 1979-12-31
PATIENT LIFT · Orthopedic Equipment Co., Inc.510(k) · 1978-06-06
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.