FDA product code LZW: Monitor, Spine Curvature
LZW is the FDA product code for monitor, spine curvature. It is a Unclassified device, reviewed by the Physical Medicine panel. FDA has cleared 5 510(k) submissions under LZW, from 5 different applicants. The average 510(k) review took 173 days (median 191).
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Spine Curvature |
| Device class | Unclassified |
| Review panel | PM — Physical Medicine |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LZW clearance
Top LZW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Perseus Althetics,Llc | 1 | 2010-08-13 |
| Peter Fischer | 1 | 2009-02-20 |
| Dan Kline | 1 | 1995-06-26 |
| Bagrad | 1 | 1990-07-27 |
| Mcdowell Ent., Inc. | 1 | 1989-06-09 |
Most recent LZW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K093553 | Perseus Althetics,Llc | POSTURETEK | 2010-08-13 | 269 |
| K081540 | Peter Fischer | ZEGRA POSTURE TRAINER | 2009-02-20 | 263 |
| K951244 | Dan Kline | SPINE TUNER POSTURE TRAINER | 1995-06-26 | 105 |
| K902669 | Bagrad | BPA, BODY POSITION ALARM | 1990-07-27 | 39 |
| K884976 | Mcdowell Ent., Inc. | MICRO-STRAIGHT POSTURE TRAINING DEVICE | 1989-06-09 | 191 |
Recalls for LZW devices
openFDA lists no recalls for product code LZW.
Frequently asked questions
What is FDA product code LZW?
LZW is the FDA product code for monitor, spine curvature. It is a Unclassified device, reviewed by the Physical Medicine panel.
What device class is LZW?
Unclassified. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LZW?
Across 5 cleared submissions the average was 173 days from receipt to decision (median 191).
Which companies have the most LZW clearances?
Perseus Althetics,Llc (1); Peter Fischer (1); Dan Kline (1); Bagrad (1); Mcdowell Ent., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LZW
- Run a recall and safety report across every LZW manufacturer
- Watch product code LZW 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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