SpineMED Decompression System S200EC
by Universal Pain Technology Canada Inc
SpineMED Decompression System S200EC is a Class II device made by Universal Pain Technology Canada Inc, cleared under FDA 510(k) K051013 on 27 Apr 2005 and listed in FDA GUDID since 30 Jun 2016 (UDI-DI M767S200EC1), active as of 23 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 | NumberM767S200EC1 | Date30 Jun 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK051013 | Date27 Apr 2005 | StatusActive |
Official records
- FDA 510(k) database K051013
Across registries
- FDA 510(k) K051013 decided 27 Apr 2005 Active
- FDA GUDID UDI-DI M767S200EC1 listed 30 Jun 2016 Listed
Timeline
- Cleared FDA 510(k) K051013
- Listed FDA GUDID M767S200EC1
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SpineMED Decompression System
- Generic name
- Programmable powered traction system
- Model / reference
- S200EC
- Primary DI / UDI-DI
- M767S200EC1
- 510(k) Number
- 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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