K221865 is an FDA 510(k) clearance for the BTL-094. This device is classified as a Massager, Therapeutic, Electric (Class I - General Controls, product code ISA).
Submitted by BTL Industries, Inc. (Marlborough, US). The FDA issued a Cleared decision on April 14, 2023, 291 days after receiving the submission on June 27, 2022.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5660.
| 510(k) Number | K221865 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2022 |
| Decision Date | April 14, 2023 |
| Days to Decision | 291 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ISA — Massager, Therapeutic, Electric |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5660 |