The following data is part of a premarket notification filed by Remed Co., Ltd with the FDA for Altms Magnetic Stimulation Therapy System.
| Device ID | K202537 |
| 510k Number | K202537 |
| Device Name: | ALTMS Magnetic Stimulation 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 | Yonsoo Nam |
| Correspondent | Kyungyoon Kang K-Biotech 201 South 4th Street, Suite 727 San Jose, CA 95112 |
| Product Code | OBP |
| CFR Regulation Number | 882.5805 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-01 |
| Decision Date | 2021-11-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809308380522 | K202537 | 000 |