ReActiv8 Programmer 6M7500-012
ReActiv8 Programmer 6M7500-012 is a Class III device made by Mainstay Medical Limited, approved under FDA PMA P190021 on 16 Jun 2020 and listed in FDA GUDID since 22 May 2025 (UDI-DI 05391527771364), active as of 23 Oct 2026.
Active
PMA
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05391527771364 | Date22 May 2025 | StatusListed |
| United States | FDA PMAAPPR | NumberP190021 | Date16 Jun 2020 | StatusActive |
Official records
- AccessGUDID record 05391527771364
- FDA PMA database P190021
Across registries
- FDA PMA P190021 decided 16 Jun 2020 Active
- FDA GUDID UDI-DI 05391527771364 listed 22 May 2025 Listed
Timeline
- Approved FDA PMA P190021
- Listed FDA GUDID 05391527771364
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- ReActiv8 Programmer
- Generic name
- Implantable electrical stimulation device management software
- Model / reference
- 6M7500-012
- Primary DI / UDI-DI
- 05391527771364
- PMA number
- FDA product code
- QLK
- GMDN term
- Implantable electrical stimulation device management software
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe