510(k) K171685
K171685 is an FDA 510(k) premarket notification submitted by Cool Systems, Inc. (Dba Game Ready) for the device "Med4 Elite". The FDA issued a decision of Substantially Equivalent on Sep 29, 2017. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Cool Systems, Inc. (Dba Game Ready) has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 29, 2017
- Date Received
- Jun 7, 2017
- 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)