FDA product code FRK: Chair, Examination And Treatment
FRK is the FDA product code for chair, examination and treatment. It is a Class I device, regulated under 21 CFR 880.6140 and reviewed by the General Hospital panel. FDA has cleared 4 510(k) submissions under FRK, from 3 different applicants. The average 510(k) review took 33 days (median 29). FDA has posted 1 recall for FRK devices.
Classification
| Field | Value |
|---|---|
| Device name | Chair, Examination And Treatment |
| Device class | Class I |
| Regulation | 21 CFR 880.6140 |
| 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 FRK clearance
Top FRK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fem-Gard, Inc. | 2 | 1979-06-20 |
| Jedmed Instrument Co. | 1 | 1989-12-18 |
| American Health Care Industries, Inc. | 1 | 1979-06-27 |
Most recent FRK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K896275 | Jedmed Instrument Co. | JEDMED J-II CHAIR | 1989-12-18 | 49 |
| K791016 | American Health Care Industries, Inc. | ULTICARE 2500 TREATMENT CHAIR | 1979-06-27 | 26 |
| K790954 | Fem-Gard, Inc. | HEEL GARD | 1979-06-20 | 29 |
| K790955 | Fem-Gard, Inc. | COVER GARD | 1979-06-20 | 29 |
Recalls for FRK devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2021-05-12.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code FRK?
FRK is the FDA product code for chair, examination and treatment. It is a Class I device, regulated under 21 CFR 880.6140 and reviewed by the General Hospital panel.
What device class is FRK?
Class I, regulation 21 CFR 880.6140. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FRK?
Across 4 cleared submissions the average was 33 days from receipt to decision (median 29).
Which companies have the most FRK clearances?
Fem-Gard, Inc. (2); Jedmed Instrument Co. (1); American Health Care Industries, Inc. (1).
Have FRK devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2021-05-12.
Next steps
- Run an FDA pathway report with predicate devices for product code FRK
- Run a recall and safety report across every FRK manufacturer
- Watch product code FRK 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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