510(k) K210240
K210240 is an FDA 510(k) premarket notification submitted by Konliking Tech & Dev. Limited for the device "Air Compression Therapy Device, model HW6007". The FDA issued a decision of Substantially Equivalent on Feb 22, 2021. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 22, 2021
- Date Received
- Jan 29, 2021
- 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)