PPS
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Sleeve, Head And Neck, Compressible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5800
- Medical specialty
- Cardiovascular
- Flags
- Third-party review eligible
- FDA definition
- Intended to move excess fluid from the target area to another area of the body.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Flexitouch System (K153311) | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2016-09-14 |
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