FDA product code FRI: Scale, Stand-On, Patient
FRI is the FDA product code for scale, stand-on, patient. It is a Class I device, regulated under 21 CFR 880.2700 and reviewed by the General Hospital panel. FDA has cleared 3 510(k) submissions under FRI, from 2 different applicants. The average 510(k) review took 23 days (median 30). FDA has posted 2 recalls for FRI devices.
Classification
| Field | Value |
|---|---|
| Device name | Scale, Stand-On, Patient |
| Device class | Class I |
| Regulation | 21 CFR 880.2700 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every FRI clearance
Top FRI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sr Instruments, Inc. | 2 | 1977-06-08 |
| Acme Medical Scale Co. | 1 | 1979-02-01 |
Most recent FRI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K790130 | Acme Medical Scale Co. | SCALE, DIGITAL CHAIR | 1979-02-01 | 9 |
| K770847 | Sr Instruments, Inc. | PORTA-SCALE | 1977-06-08 | 30 |
| K770848 | Sr Instruments, Inc. | DAILY-WEIGHT | 1977-06-08 | 30 |
Recalls for FRI devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-12-23.
Frequently asked questions
What is FDA product code FRI?
FRI is the FDA product code for scale, stand-on, patient. It is a Class I device, regulated under 21 CFR 880.2700 and reviewed by the General Hospital panel.
What device class is FRI?
Class I, regulation 21 CFR 880.2700. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FRI?
Across 3 cleared submissions the average was 23 days from receipt to decision (median 30).
Which companies have the most FRI clearances?
Sr Instruments, Inc. (2); Acme Medical Scale Co. (1).
Have FRI devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2015-12-23.
Next steps
- Run an FDA pathway report with predicate devices for product code FRI
- Run a recall and safety report across every FRI manufacturer
- Watch product code FRI 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.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times