FDA product code FRW: Scale, Patient
FRW is the FDA product code for scale, patient. It is a Class I device, regulated under 21 CFR 880.2720 and reviewed by the General Hospital panel. FDA has cleared 48 510(k) submissions under FRW, from 28 different applicants. The average 510(k) review took 102 days (median 66). FDA has posted 7 recalls for FRW devices.
Classification
| Field | Value |
|---|---|
| Device name | Scale, Patient |
| Device class | Class I |
| Regulation | 21 CFR 880.2720 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FRW clearance
Top FRW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympic Medical Corp. | 7 | 1996-01-30 |
| Acme Medical Scale Co. | 7 | 1993-10-25 |
| Scale-Tronix, Inc. | 3 | 1992-03-27 |
| U.S. Medical Corp. | 3 | 1991-03-21 |
| Seca Corp. | 3 | 1982-07-30 |
23 more applicants have FRW clearances. See the full list in Caduvo.
Most recent FRW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K955357 | Olympic Medical Corp. | OLYMPIC SMART SCALE MODEL 50/50RA | 1996-01-30 | 99 |
| K955177 | Olympic Medical Corp. | OLYMPIC SMART SCALE | 1995-12-14 | 31 |
| K954846 | Olympic Medical Corp. | OLYMPIC SMART SCALE | 1995-12-14 | 52 |
| K952649 | Olympic Medical Corp. | WARM-SCALE | 1995-08-15 | 67 |
| K943587 | Future Systems, Inc. | ADVANCED IN-BED WEIGH SYSTEM | 1994-09-22 | 62 |
Recalls for FRW devices
7 product recalls in 5 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2019-06-19.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code FRW?
FRW is the FDA product code for scale, patient. It is a Class I device, regulated under 21 CFR 880.2720 and reviewed by the General Hospital panel.
What device class is FRW?
Class I, regulation 21 CFR 880.2720. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FRW?
Across 48 cleared submissions the average was 102 days from receipt to decision (median 66).
Which companies have the most FRW clearances?
Olympic Medical Corp. (7); Acme Medical Scale Co. (7); Scale-Tronix, Inc. (3); U.S. Medical Corp. (3); Seca Corp. (3).
Have FRW devices been recalled?
Yes: 7 product recalls across 5 recall events; the most recent began 2019-06-19.
Next steps
- Run an FDA pathway report with predicate devices for product code FRW
- Run a recall and safety report across every FRW manufacturer
- Watch product code FRW 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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