510(k) K240959
K240959 is an FDA 510(k) premarket notification submitted by Chongqing Moffy Innovation Technology Co., Ltd. for the device "Respiratory Muscle Trainer". The FDA issued a decision of Substantially Equivalent on December 18, 2024. The device falls under product code BYI (Percussor, Powered-Electric), a Class II device regulated under 21 CFR 868.5665. Chongqing Moffy Innovation Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2024
- Date Received
- April 8, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Percussor, Powered-Electric
- Device Class
- Class II
- Regulation Number
- 868.5665
- Review Panel
- AN
- Submission Type