K212723 is an FDA 510(k) clearance for the BTL-995-rTMS. This device is classified as a Transcranial Magnetic Stimulator (Class II — Special Controls, product code OBP).
Submitted by BTL Industries, Inc. (Malborough, US). The FDA issued a Cleared decision on March 4, 2022, 189 days after receiving the submission on August 27, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5805. A Transcranial Magnetic Stimulator Is A Device That Delivers Brief Duration, Rapidly Alternating, Or Pulsed, Magnetic Fields To Induce Electrical Currents That Are Directed At Spatially Discrete Regions Of The Cerebral Cortex For The Treatment Of Major Depressive Disorder..
| 510(k) Number | K212723 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 2021 |
| Decision Date | March 04, 2022 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | OBP — Transcranial Magnetic Stimulator |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.5805 |
| Definition | A Transcranial Magnetic Stimulator Is A Device That Delivers Brief Duration, Rapidly Alternating, Or Pulsed, Magnetic Fields To Induce Electrical Currents That Are Directed At Spatially Discrete Regions Of The Cerebral Cortex For The Treatment Of Major Depressive Disorder. |