510(k) K251088
K251088 is an FDA 510(k) premarket notification submitted by Otsuka America Pharmaceutical, Inc. for the device "Otsuka Digital Feedback Device". The FDA issued a decision of Substantially Equivalent on June 30, 2025. The device falls under product code OZW (Ingestible Event Marker), a Class II device regulated under 21 CFR 880.6305. Otsuka America Pharmaceutical, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 2025
- Date Received
- April 9, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ingestible Event Marker
- Device Class
- Class II
- Regulation Number
- 880.6305
- Review Panel
- CV
- Submission Type
To provide confirmation of an event co-ingested or coincident with the ingestible component of the device. The wearable component of the device incorporates wireless communication to display the event and other information on a general computing device