Chrysalis Intelligence · Sponsors · Permobil AB

Permobil AB

Timra, SE · 1 510(k) clearances · 2 recalls

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Total clearances
1
2020-02-27 → 2020-02-27
Last 12 months
0
Product codes
1
Most recent
2020-02-27
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
IPL Wheelchair, Standup Class II Physical Medicine 1 2020-02-27
Safety

Recalls (2)

Class I (serious)
0
Risk of injury / death
Total recalls
2
Currently ongoing
2
Most recent
2023-05-10
DateSeverityStatusRecall # ProductCodeReason
2023-05-10 Class II Ongoing Z-2005-2023 PushTracker E3 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32P… — When multiple processes are running on the watch's Central Processing Unit (CPU), the application may fail unexpectedly. If this happens, the motor on the power…
2023-05-10 Class II Ongoing Z-2004-2023 PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32P… — When multiple processes are running on the watch's Central Processing Unit (CPU), the application may fail unexpectedly. If this happens, the motor on the power…
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2020-02-27 K190682 Explorer Mini IPL Class II Physical Medicine
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence