510(k) K172384
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