FDA product code FZK: Chair, Surgical, Non-Electrical
FZK is the FDA product code for chair, surgical, non-electrical. It is a Class I device, regulated under 21 CFR 878.4950 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under FZK, from 2 different applicants. The average 510(k) review took 117 days (median 117).
Classification
| Field | Value |
|---|---|
| Device name | Chair, Surgical, Non-Electrical |
| Device class | Class I |
| Regulation | 21 CFR 878.4950 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FZK clearance
Top FZK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Keymed (Medical & Industrial Equipment), Ltd. | 1 | 1996-12-12 |
| Neutral Pos-Chair Co. | 1 | 1984-07-23 |
Most recent FZK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K962528 | Keymed (Medical & Industrial Equipment), Ltd. | OLYMPUS MOBILE CHAIR/COUCH | 1996-12-12 | 168 |
| K842030 | Neutral Pos-Chair Co. | NEUTRAL POS-CHAIR SURGEON CHAIR | 1984-07-23 | 66 |
Recalls for FZK devices
openFDA lists no recalls for product code FZK.
Frequently asked questions
What is FDA product code FZK?
FZK is the FDA product code for chair, surgical, non-electrical. It is a Class I device, regulated under 21 CFR 878.4950 and reviewed by the General and Plastic Surgery panel.
What device class is FZK?
Class I, regulation 21 CFR 878.4950. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FZK?
Across 2 cleared submissions the average was 117 days from receipt to decision (median 117).
Which companies have the most FZK clearances?
Keymed (Medical & Industrial Equipment), Ltd. (1); Neutral Pos-Chair Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FZK
- Run a recall and safety report across every FZK manufacturer
- Watch product code FZK 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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