Monitor, Spine Curvature
The Spine Curvature Monitor (product code LZW) is a physical medicine device used to measure and track spinal curvature over time, assisting in the management and treatment of scoliosis and other spinal deformities. It is currently unclassified (Class U) with no assigned regulation number or formal medical specialty, and is reviewed under the Physical Medicine (PM) panel. As an unclassified device, its regulatory pathway has not been fully determined. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- LZW
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- PM
- Submission Type
- 7
Device Characteristics
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K093553 | POSTURETEK | Aug 13, 2010 | Substantially Equivalent | Perseus Althetics,Llc |
| K081540 | ZEGRA POSTURE TRAINER | Feb 20, 2009 | Substantially Equivalent | Peter Fischer |
| K951244 | SPINE TUNER POSTURE TRAINER | Jun 26, 1995 | Substantially Equivalent | Dan Kline |
| K902669 | BPA, BODY POSITION ALARM | Jul 27, 1990 | Substantially Equivalent | Bagrad |
| K884976 | MICRO-STRAIGHT POSTURE TRAINING DEVICE | Jun 09, 1989 | Substantially Equivalent | Mcdowell Ent., Inc. |