The following data is part of a premarket notification filed by Remed Co., Ltd with the FDA for Altms Magnetic Stimulation Therapy System, Blossom Tms Therapy System.
| Device ID | K220625 |
| 510k Number | K220625 |
| Device Name: | ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System |
| Classification | Transcranial Magnetic Stimulator |
| Applicant | REMED Co., Ltd #301-#303 Migun Techno World II, 187, Techno 2-Ro Yuseong-gu Daejeon, KR 34025 |
| Contact | Yuna Cho |
| Correspondent | Soojung Moon Allura Medical Solutions Inc. 5485 Rathdrum Way Antioch, CA 94531 |
| Product Code | OBP |
| CFR Regulation Number | 882.5805 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-03 |
| Decision Date | 2022-04-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809308380546 | K220625 | 000 |
| 08809308380539 | K220625 | 000 |