The following data is part of a premarket notification filed by Ito Co., Ltd. with the FDA for Sw-180 Shortwave Therapy Unit.
| Device ID | K022846 |
| 510k Number | K022846 |
| Device Name: | SW-180 SHORTWAVE THERAPY UNIT |
| Classification | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
| Applicant | ITO CO., LTD. 2305 GOLD MINE RD. Brookeville, MD 20833 |
| Contact | T. Whit Athey |
| Correspondent | T. Whit Athey ITO CO., LTD. 2305 GOLD MINE RD. Brookeville, MD 20833 |
| Product Code | IMJ |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-27 |
| Decision Date | 2003-01-28 |
| Summary: | summary |