Submission Details
| 510(k) Number | K213097 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Armory Motion
Jun 2022
Decision
259d
Days
Class 2
Risk
About This 510(k) Submission
K213097 is an FDA 510(k) clearance for the Armory Motion, 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 review panel. Regulated under 21 CFR 890.5720.
Device Classification
| Product Code | ILO — Pack, Hot Or Cold, Water Circulating |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.5720 |
Manufacturer
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