510(k) K243177
K243177 is an FDA 510(k) premarket notification submitted by Elastimed , Ltd. for the device "SACS PRO". The FDA issued a decision of Substantially Equivalent on Dec 23, 2024. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Elastimed , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 23, 2024
- Date Received
- Sep 30, 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