Blue Arm Sleeve 5 Cell Left Arm Sleeve Blue
Blue Arm Sleeve 5 Cell Left Arm Sleeve Blue (20301) is an intermittent venous compression system (FDA Class II) made by Normatec Industries, LP, cleared under FDA 510(k) K112890 on 4 Jan 2012 (1 earlier submission) and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00817369020422), 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 | Number00817369020422 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK112890 | Date4 Jan 2012 | StatusActive |
Official records
- AccessGUDID record 00817369020422
- FDA 510(k) database K112890
- FDA 510(k) database K013436
Across registries
- FDA 510(k) K112890 decided 4 Jan 2012 Active
- FDA GUDID UDI-DI 00817369020422 listed 22 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K013436
- Cleared FDA 510(k) K112890
- Listed FDA GUDID 00817369020422
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Blue Arm Sleeve
- Generic name
- Intermittent venous compression system
- Model / Ref / Catalog
- 5 Cell Left Arm Sleeve Blue, 20301
- Primary DI / UDI-DI
- 00817369020422
- FDA product code
- JOW, IRP
- GMDN term
- Intermittent venous compression system
- Device class
- Class II
- Regulation number
- 870.5800, 890.5650
- GUDID distribution status
- In Commercial Distribution
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