K213097 is an FDA 510(k) clearance for the Armory Motion. This device is classified as a Pack, Hot Or Cold, Water Circulating (Class II - Special Controls, product code ILO).
Submitted by Pain Management Technologies, Inc. (Akron, US). The FDA issued a Cleared decision on June 10, 2022, 259 days after receiving the submission on September 24, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 890.5720.
| 510(k) Number | K213097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2021 |
| Decision Date | June 10, 2022 |
| Days to Decision | 259 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | ILO - Pack, Hot Or Cold, Water Circulating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5720 |