LQX
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Device, Finger-Sucking
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3475
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1996: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| T-GUARD (K945537) | Med ET AL Development | 1995-03-23 | + Add |
| THUMBSHELPER POWER RING (K864870) | Levolon Company, Inc. | 1987-02-12 | + Add |
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Every clearance here is in the API, with alerts when new ones post.