Submission Details
| 510(k) Number | K220217 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 26, 2022 |
| Decision Date | February 25, 2022 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
Cleared
Traditional
K220217 - Normatec 3
(FDA 510(k) Clearance)
Feb 2022
Decision
30d
Days
Class 2
Risk
K220217 is an FDA 510(k) clearance for the Normatec 3, a Massager, Powered Inflatable Tube (Class II — Special Controls, product code IRP), submitted by NormaTec Industries, LP (Watertown, US). The FDA issued a Cleared decision on February 25, 2022, 30 days after receiving the submission on January 26, 2022. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5650.
Device Classification
| Product Code | IRP — Massager, Powered Inflatable Tube |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.5650 |
Similar Devices — IRP Massager, Powered Inflatable Tube
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