The following data is part of a premarket notification filed by Ito Co., Ltd. with the FDA for Tm-400.
| Device ID | K081247 |
| 510k Number | K081247 |
| Device Name: | TM-400 |
| Classification | Equipment, Traction, Powered |
| Applicant | ITO CO., LTD. 1201 RICHARDSON DR., SUITE 140 Richardson, TX 75080 |
| Contact | Kenneth L Block |
| Correspondent | Kenneth L Block ITO CO., LTD. 1201 RICHARDSON DR., SUITE 140 Richardson, TX 75080 |
| Product Code | ITH |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-01 |
| Decision Date | 2008-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04983087007932 | K081247 | 000 |