510(k) K220217
K220217 is an FDA 510(k) premarket notification submitted by NormaTec Industries, LP for the device "Normatec 3". The FDA issued a decision of Substantially Equivalent on Feb 25, 2022. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. NormaTec Industries, LP has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 25, 2022
- Date Received
- Jan 26, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Massager, Powered Inflatable Tube
- Device Class
- Class II
- Regulation Number
- 890.5650
- Review Panel
- PM
- Submission Type