PCD Boot 3 Cell Zippered Boot
PCD Boot 3 Cell Zippered Boot (20113) is a sequential venous compression system (FDA Class II; FDA product code JOW, Sleeve, Limb, Compressible) made by Normatec Industries, LP, cleared under FDA 510(k) K161346 on 15 Jun 2016 and listed in FDA GUDID since 7 Nov 2016 (UDI-DI 00817369022389), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00817369022389 | Date7 Nov 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK161346 | Date15 Jun 2016 | StatusActive |
Official records
- AccessGUDID record 00817369022389
- FDA 510(k) database K161346
Across registries
- FDA 510(k) K161346 decided 15 Jun 2016 Active
- FDA GUDID UDI-DI 00817369022389 listed 7 Nov 2016 Listed
Timeline
- Cleared FDA 510(k) K161346
- Listed FDA GUDID 00817369022389
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PCD Boot
- Generic name
- Sequential venous compression system
- Model / Ref / Catalog
- 3 Cell Zippered Boot, 20113
- Primary DI / UDI-DI
- 00817369022389
- 510(k) Number
- FDA product code
- JOW
- GMDN term
- Sequential venous compression system
- Device class
- Class II
- Regulation number
- 870.5800
- GUDID distribution status
- In Commercial Distribution
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