ReActiv8 IPG 7M5100-005
ReActiv8 IPG 7M5100-005 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 13 Feb 2025 (UDI-DI 05391527770046), 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 | Number05391527770046 | Date13 Feb 2025 | StatusListed |
| United States | FDA PMAAPPR | NumberP190021 | Date16 Jun 2020 | StatusActive |
Official records
- AccessGUDID record 05391527770046
- FDA PMA database P190021
Across registries
- FDA PMA P190021 decided 16 Jun 2020 Active
- FDA GUDID UDI-DI 05391527770046 listed 13 Feb 2025 Listed
Timeline
- Approved FDA PMA P190021
- Listed FDA GUDID 05391527770046
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- ReActiv8 IPG
- Generic name
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
- Model / Ref / Catalog
- 7M5100-005, 5100
- Primary DI / UDI-DI
- 05391527770046
- PMA number
- FDA product code
- QLK
- GMDN term
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
Similar devices in this category
Other devices filed under Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable.