Imported Pain Control Device
by Empi
510(k) K771885
Imported Pain Control Device is a Class II device made by Empi, cleared under FDA 510(k) K771885 on 2 Nov 1977, active as of 26 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 | NumberK771885 | Date2 Nov 1977 | StatusActive |
Official records
- FDA 510(k) database K771885
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GZJ
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5890
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
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- ANASTIM II TRANSCUTANEOUS ELECTRICAL by Biostim, Inc.
- TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR by General Medical Industries, Inc.
- K-DISPERSE by KATECHO LLC