The following data is part of a premarket notification filed by Ito Co., Ltd. with the FDA for Us-101l, Us-103s.
| Device ID | K112520 |
| 510k Number | K112520 |
| Device Name: | US-101L, US-103S |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | ITO CO., LTD. 3-3-3 TOYOTAMA-MINAMI NERIMA-KU Tokyo, JP 176-0014 |
| Contact | Haruhisa Okada |
| Correspondent | Alexander Schapovalov TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-08-31 |
| Decision Date | 2011-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816864020272 | K112520 | 000 |
| 00816864020265 | K112520 | 000 |