Stimulation System PR4
Stimulation System PR4 is a Class II device made by Edan Instruments, Inc., cleared under FDA 510(k) K232786 on 16 May 2024 and listed in FDA GUDID since 15 May 2026 (UDI-DI 06944413866164), 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 | Number06944413866164 | Date15 May 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK232786 | Date16 May 2024 | StatusActive |
Official records
- AccessGUDID record 06944413866164
- FDA 510(k) database K232786
Across registries
- FDA 510(k) K232786 decided 16 May 2024 Active
- FDA GUDID UDI-DI 06944413866164 listed 15 May 2026 Listed
Timeline
- Cleared FDA 510(k) K232786
- Listed FDA GUDID 06944413866164
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Stimulation System
- Generic name
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Model / reference
- PR4
- Primary DI / UDI-DI
- 06944413866164
- 510(k) Number
- FDA product code
- IPF, GZJ
- GMDN term
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Device class
- Class II
- Regulation number
- 890.5850, 882.5890
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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