Infinity Electrotherapy System
by Empi
510(k) K042057
Infinity Electrotherapy System is a Class II device made by Empi, cleared under FDA 510(k) K042057 on 17 Dec 2004, 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 | FDA 510(k)SESE | NumberK042057 | Date17 Dec 2004 | StatusActive |
Official records
- FDA 510(k) database K042057
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LIH
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5890
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
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