510(k) K172384

Quickie(r) Q700-UP M by Sunrise Medical (Us), LLC — Product Code IPL

K172384 is an FDA 510(k) premarket notification submitted by Sunrise Medical (Us), LLC for the device "Quickie(r) Q700-UP M". The FDA issued a decision of Substantially Equivalent on January 16, 2018. The device falls under product code IPL (Wheelchair, Standup), a Class II device regulated under 21 CFR 890.3900. Sunrise Medical (Us), LLC has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2018
Date Received
August 8, 2017
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