The following data is part of a premarket notification filed by Ito Co., Ltd. with the FDA for Trio 300.
| Device ID | K990787 |
| 510k Number | K990787 |
| Device Name: | TRIO 300 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | ITO CO., LTD. 2300 TWINBROOK PARKWAY, SUITE 625 Rockville, MD 20852 |
| Contact | T. Whit Athey |
| Correspondent | T. Whit Athey ITO CO., LTD. 2300 TWINBROOK PARKWAY, SUITE 625 Rockville, MD 20852 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-10 |
| Decision Date | 1999-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816864020401 | K990787 | 000 |