510(k) K041877
K041877 is an FDA 510(k) premarket notification submitted by Health Ent., Inc. for the device "ACU-STRAP MOTION SICKNESS BAND". The FDA issued a decision of Substantially Equivalent on Oct 8, 2004. The device falls under product code MVV (Device, Acupressure), a Class U device.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 8, 2004
- Date Received
- Jul 12, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Device, Acupressure
- Device Class
- Class U
- Review Panel
- NE
- Submission Type
- Enforcement Discretion