Chrysalis Intelligence · Sponsors · Sunrise Medical (Us), LLC

Sunrise Medical (Us), LLC

Fresno, CA, US · 1 510(k) clearances · 3 recalls

Total clearances
1
2022-03-30 → 2022-03-30
Last 12 months
0
Product codes
1
Most recent
2022-03-30
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
ITI Wheelchair, Powered Class II Physical Medicine 1 2022-03-30
Safety

Recalls (3)

Class I (serious)
0
Risk of injury / death
Total recalls
3
Currently ongoing
0
Most recent
2021-07-08
DateSeverityStatusRecall # ProductCodeReason
2021-07-08 Class II Terminated Z-2158-2021 Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assistin… The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
2021-07-08 Class II Terminated Z-2157-2021 Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assistin… The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
2020-02-13 Class II Terminated Z-1947-2020 Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is controlled by Power… Due to programming errors in the Controller, an increase in the set motor parameters can be made by the end user beyond tested safe limits.
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2022-03-30 K220213 Empulse R90 ITI Class II Physical Medicine