510(k) K122562
K122562 is an FDA 510(k) premarket notification submitted by E-Teng Technology, Inc. for the device "E-TENG MODEL EOR 1". The FDA issued a decision of Substantially Equivalent on August 9, 2013. The device falls under product code IPL (Wheelchair, Standup), a Class II device regulated under 21 CFR 890.3900.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 9, 2013
- Date Received
- August 22, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wheelchair, Standup
- Device Class
- Class II
- Regulation Number
- 890.3900
- Review Panel
- PM
- Submission Type