510(k) K191441
K191441 is an FDA 510(k) premarket notification submitted by Maxstar Industrial Co., Ltd. for the device "Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)". The FDA issued a decision of Substantially Equivalent on Mar 5, 2021. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Maxstar Industrial Co., Ltd. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 5, 2021
- Date Received
- May 30, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Massager, Powered Inflatable Tube
- Device Class
- Class II
- Regulation Number
- 890.5650
- Review Panel
- PM
- Submission Type
- 510(k)