The following data is part of a premarket notification filed by Magstim Company Limited with the FDA for Rapid Therapy System.
| Device ID | K143531 |
| 510k Number | K143531 |
| Device Name: | Rapid Therapy System |
| Classification | Transcranial Magnetic Stimulator |
| Applicant | MAGSTIM COMPANY LIMITED SPRING GARDENS, WHITLAND Carmarthenshire, GB Sa34 Ohr |
| Contact | Charles Hounsell |
| Correspondent | Steven B Datlof HOGAN LOVELLS US LLP 1835 MARKET ST 29TH FL Philadelphia, PA 19103 |
| Product Code | OBP |
| CFR Regulation Number | 882.5805 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-12 |
| Decision Date | 2015-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060229532138 | K143531 | 000 |
| 05060229531933 | K143531 | 000 |
| 05060229531889 | K143531 | 000 |