300 Pv Complete Electrotherapy System
by Empi
510(k) K021100
300 Pv Complete Electrotherapy System is a medical device (FDA Class II; FDA product code IPF, Stimulator, Muscle, Powered) made by Empi, cleared under FDA 510(k) K021100 on 18 Jun 2002, 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 | NumberK021100 | Date18 Jun 2002 | StatusActive |
Official records
- FDA 510(k) database K021100
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IPF
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K021100
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| EMPI 300PV Stimulator | 11008 / 0 | B36711008L00 | — | On the market |
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