FDA product code FNG: Lift, Patient, Ac-Powered
FNG is the FDA product code for lift, patient, ac-powered. It is a Class II device, regulated under 21 CFR 880.5500 and reviewed by the General Hospital panel. FDA has cleared 21 510(k) submissions under FNG, from 16 different applicants. The average 510(k) review took 96 days (median 66). FDA has posted 23 recalls for FNG devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Lift, Patient, Ac-Powered |
| Device class | Class II |
| Regulation | 21 CFR 880.5500 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FNG clearance
Top FNG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Century Manufacturing Co. | 5 | 1991-10-02 |
| Bomdal Medical Equipment, Inc. | 2 | 1986-07-15 |
| D.T. Davis Enterprises Ltd. T/A Hovertech Int'L | 1 | 2012-10-03 |
| D.T. Davis Enterprises , Ltd. | 1 | 2004-08-12 |
| Arylift, Inc. | 1 | 1994-10-13 |
11 more applicants have FNG clearances. See the full list in Caduvo.
Most recent FNG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K121287 | D.T. Davis Enterprises Ltd. T/A Hovertech Int'L | HT-WEDGE | 2012-10-03 | 156 |
| K041503 | D.T. Davis Enterprises , Ltd. | HOVERJACK AIR PATIENT LIFT DEVICE | 2004-08-12 | 66 |
| K940872 | Arylift, Inc. | PATIENT SUPPORT SYSTEM | 1994-10-13 | 230 |
| K935351 | Ken Kemmerer | A.C. POWER PATIENT LIFT | 1994-02-28 | 115 |
| K926411 | Arjo-Century, Inc. | SAF-LIFT/SAF-KARY | 1993-03-31 | 100 |
Recalls for FNG devices
23 product recalls in 9 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-01-25.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code FNG?
FNG is the FDA product code for lift, patient, ac-powered. It is a Class II device, regulated under 21 CFR 880.5500 and reviewed by the General Hospital panel.
What device class is FNG?
Class II, regulation 21 CFR 880.5500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FNG?
Across 21 cleared submissions the average was 96 days from receipt to decision (median 66).
Which companies have the most FNG clearances?
Century Manufacturing Co. (5); Bomdal Medical Equipment, Inc. (2); D.T. Davis Enterprises Ltd. T/A Hovertech Int'L (1); D.T. Davis Enterprises , Ltd. (1); Arylift, Inc. (1).
Have FNG devices been recalled?
Yes: 23 product recalls across 9 recall events; the most recent began 2024-01-25.
Next steps
- Run an FDA pathway report with predicate devices for product code FNG
- Run a recall and safety report across every FNG manufacturer
- Watch product code FNG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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