510(k) K241256
K241256 is an FDA 510(k) premarket notification submitted by Therabody, Inc. for the device "JetBoots PRO Plus". The FDA issued a decision of Substantially Equivalent on August 30, 2024. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Therabody, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 30, 2024
- Date Received
- May 6, 2024
- 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