The following data is part of a premarket notification filed by Lpg Usa, Inc. with the FDA for Lpg Therapeutic Massager, Models -esi, Therapeutic Massager/vibrator.
| Device ID | K990445 |
| 510k Number | K990445 |
| Device Name: | LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR |
| Classification | Massager, Therapeutic, Electric |
| Applicant | LPG USA, INC. 3101 NORTH FEDERAL HWY. #300 Fort Lauderdale, FL 33306 |
| Contact | Jocelyne Rolland |
| Correspondent | Jocelyne Rolland LPG USA, INC. 3101 NORTH FEDERAL HWY. #300 Fort Lauderdale, FL 33306 |
| Product Code | ISA |
| CFR Regulation Number | 890.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-10 |
| Decision Date | 2000-01-18 |
| Summary: | summary |