LLK
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Legging, Compression, Non-Inflatable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5780
- Medical specialty
- General Hospital
- Adverse events (MAUDE)
- 1993: 1 · 1994: 1 · 2016: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| UNNA-SLEEVE(TM) (K903532) | Aci Medical, Inc. | 1990-11-02 |
| TECNOL COMPRESSION KNEE DRESSING (K873368) | Tecnol New Jersey Wound Care, Inc. | 1987-12-11 |
| COMPRESSION LEGGING DEVICE (K871889) | A-T Surgical Mfg. Co., Inc. | 1987-08-04 |
| MODEL 1888 ALPHA COS/RESPIRATION CAR (K834460) | Spacelabs, Inc. | 1984-02-13 |
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Every clearance here is in the API, with alerts when new ones post.