Decompression of Choice E9011
Decompression of Choice E9011 is a Class II device made by Pivotal Health Solutions, listed in FDA GUDID since 16 Oct 2018 (UDI-DI 00852753008907), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00852753008907 | Date16 Oct 2018 | StatusListed |
Official records
- AccessGUDID record 00852753008907
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Decompression of Choice
- Generic name
- Programmable powered traction system
- Model / reference
- E9011
- Primary DI / UDI-DI
- 00852753008907
- FDA product code
- ITH
- GMDN term
- Programmable powered traction system
- Device class
- Class II
- Regulation number
- 890.5900
- GUDID distribution status
- In Commercial Distribution
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- DRS SYSTEM by Professional Distribution Systems, Inc.