The following data is part of a premarket notification filed by Life Balance Intl., Inc. with the FDA for Lb-2000 Cranial Electrotherapy Stimulator.
| Device ID | K910616 |
| 510k Number | K910616 |
| Device Name: | LB-2000 CRANIAL ELECTROTHERAPY STIMULATOR |
| Classification | Cranial Electrotherapy Stimulator To Treat Depression |
| Applicant | LIFE BALANCE INTL., INC. 13100 SOUTH 300 East Draper, UT 84020 |
| Contact | Kelly D Grover |
| Correspondent | Kelly D Grover LIFE BALANCE INTL., INC. 13100 SOUTH 300 East Draper, UT 84020 |
| Product Code | JXK |
| CFR Regulation Number | 882.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-12 |
| Decision Date | 1992-05-12 |