510(k) K812719
K812719 is an FDA 510(k) premarket notification submitted by Bandwagon, Inc. for the device "PROSANA BELT". The FDA issued a decision of Substantially Equivalent on October 6, 1981. The device falls under product code IQE (Orthosis, Lumbar), a Class I device regulated under 21 CFR 890.3490.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 6, 1981
- Date Received
- September 25, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Lumbar
- Device Class
- Class I
- Regulation Number
- 890.3490
- Review Panel
- PM
- Submission Type