510(k) K122562

E-TENG MODEL EOR 1 by E-Teng Technology, Inc. — Product Code IPL

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