510(k) K173158
K173158 is an FDA 510(k) premarket notification submitted by Maxstar Industrial Co., Ltd. for the device "Air Relax". The FDA issued a decision of Substantially Equivalent on May 30, 2019. 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
- May 30, 2019
- Date Received
- Sep 29, 2017
- Clearance Type
- Special
- 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)