Pulse Recovery Package - Power Standard
Pulse Recovery Package - Power Standard (40104) is an intermittent venous compression system (FDA Class II; FDA product code IRP, Massager, Powered Inflatable Tube) made by Normatec Industries, LP, cleared under FDA 510(k) K160608 on 13 Apr 2016 and listed in FDA GUDID since 13 Sep 2016 (UDI-DI 00817369020910), 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 | Number00817369020910 | Date13 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160608 | Date13 Apr 2016 | StatusActive |
Official records
- AccessGUDID record 00817369020910
- FDA 510(k) database K160608
Across registries
- FDA 510(k) K160608 decided 13 Apr 2016 Active
- FDA GUDID UDI-DI 00817369020910 listed 13 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K160608
- Listed FDA GUDID 00817369020910
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Pulse Recovery Package
- Generic name
- Intermittent venous compression system
- Model / Ref / Catalog
- Pulse Recovery Package - Power Standard, 40104
- Primary DI / UDI-DI
- 00817369020910
- 510(k) Number
- FDA product code
- IRP
- GMDN term
- Intermittent venous compression system
- Device class
- Class II
- Regulation number
- 890.5650
- GUDID distribution status
- In Commercial Distribution
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