The following data is part of a premarket notification filed by China Chongqing Bashan Instrument Factory with the FDA for The Special Electromagnetic Therapeutic Apparatus.
| Device ID | K963728 |
| 510k Number | K963728 |
| Device Name: | THE SPECIAL ELECTROMAGNETIC THERAPEUTIC APPARATUS |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | CHINA CHONGQING BASHAN INSTRUMENT FACTORY 307 W. MAIN ST. SUITE 10 Alhambra, CA 91801 |
| Contact | Lu Rao |
| Correspondent | Lu Rao CHINA CHONGQING BASHAN INSTRUMENT FACTORY 307 W. MAIN ST. SUITE 10 Alhambra, CA 91801 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-17 |
| Decision Date | 1996-12-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B465CQ360 | K963728 | 000 |
| B465CQ29II0 | K963728 | 000 |
| B465CQ29CN0 | K963728 | 000 |
| B465CQ290 | K963728 | 000 |
| B465CQ270 | K963728 | 000 |
| B465CQ180 | K963728 | 000 |