FDA product code FRZ: Device, Patient Transfer, Powered
FRZ is the FDA product code for device, patient transfer, powered. It is a Class II device, regulated under 21 CFR 880.6775 and reviewed by the General Hospital panel. FDA has cleared 5 510(k) submissions under FRZ, from 5 different applicants. The average 510(k) review took 178 days (median 125). FDA has posted 2 recalls for FRZ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Device, Patient Transfer, Powered |
| Device class | Class II |
| Regulation | 21 CFR 880.6775 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FRZ clearance
Top FRZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diacor, Inc. | 1 | 2013-01-17 |
| American Invalift Corp. | 1 | 1992-06-09 |
| Lehigh Consolidated Industries | 1 | 1984-06-05 |
| R&D Systems, Inc. | 1 | 1984-05-02 |
| Lancer Assoc. | 1 | 1984-04-20 |
Most recent FRZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K121929 | Diacor, Inc. | ZEPHYR 'X-SERIES PATIENT TRANSFER SLED | 2013-01-17 | 199 |
| K910830 | American Invalift Corp. | INVALIFT | 1992-06-09 | 468 |
| K841728 | Lehigh Consolidated Industries | LCI MEDICAL INC AIR/PAL | 1984-06-05 | 41 |
| K834585 | R&D Systems, Inc. | CELLTRAK-B | 1984-05-02 | 125 |
| K840796 | Lancer Assoc. | TENDER LIFTING CARE | 1984-04-20 | 57 |
Recalls for FRZ devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-06-21.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code FRZ?
FRZ is the FDA product code for device, patient transfer, powered. It is a Class II device, regulated under 21 CFR 880.6775 and reviewed by the General Hospital panel.
What device class is FRZ?
Class II, regulation 21 CFR 880.6775. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FRZ?
Across 5 cleared submissions the average was 178 days from receipt to decision (median 125).
Which companies have the most FRZ clearances?
Diacor, Inc. (1); American Invalift Corp. (1); Lehigh Consolidated Industries (1); R&D Systems, Inc. (1); Lancer Assoc. (1).
Have FRZ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2023-06-21.
Next steps
- Run an FDA pathway report with predicate devices for product code FRZ
- Run a recall and safety report across every FRZ manufacturer
- Watch product code FRZ 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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