The following data is part of a premarket notification filed by Ito Co., Ltd. with the FDA for Model Es-130.
| Device ID | K081943 |
| 510k Number | K081943 |
| Device Name: | MODEL ES-130 |
| Classification | Stimulator, Electro-acupuncture |
| 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 | BWK |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-08 |
| Decision Date | 2008-11-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04983087008403 | K081943 | 000 |