510(k) K133057
K133057 is an FDA 510(k) premarket notification submitted by Westmed, Inc. for the device "VIBRALUNG ACOUSTICAL PERCUSSOR". The FDA issued a decision of Substantially Equivalent on May 23, 2014. The device falls under product code SDT (Intra-Pulmonary Percussive Vibration (Ipv) Devices), a Class II device regulated under 21 CFR 868.5665. Westmed, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 2014
- Date Received
- September 27, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intra-Pulmonary Percussive Vibration (Ipv) Devices
- Device Class
- Class II
- Regulation Number
- 868.5665
- Review Panel
- AN
- Submission Type
It is intended to mobilize mucus using vibration and/or pressure delivered through a mouthpiece into the airways.