510(k) K212491
K212491 is an FDA 510(k) premarket notification submitted by Diode Art Engineering Doing Business AS Air Relax for the device "Air Relax Pro Model AR-4.0". The FDA issued a decision of Substantially Equivalent on Sep 2, 2021. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Diode Art Engineering Doing Business AS Air Relax has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 2, 2021
- Date Received
- Aug 9, 2021
- 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
- 510(k)