510(k) K191179
K191179 is an FDA 510(k) premarket notification submitted by Otto Bock Healthcare Products GmbH for the device "Myo Plus". The FDA issued a decision of Substantially Equivalent on September 4, 2019. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Otto Bock Healthcare Products GmbH has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 4, 2019
- Date Received
- May 2, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Cutaneous
- Device Class
- Class II
- Regulation Number
- 882.1320
- Review Panel
- NE
- Submission Type