510(k) K954162
K954162 is an FDA 510(k) premarket notification submitted by Ergo-Air, Inc. for the device "ERGOSEAT SYSTEM". The FDA issued a decision of Substantially Equivalent on October 30, 1995. The device falls under product code MOC (Cushion, Flotation, Therapeutic), a Class II device regulated under 21 CFR 890.5170. Ergo-Air, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 1995
- Date Received
- September 5, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cushion, Flotation, Therapeutic
- Device Class
- Class II
- Regulation Number
- 890.5170
- Review Panel
- PM
- Submission Type