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Fuze Manual Tilt Wheelchair
Model FUZE T50 · PDG Product Design Group Inc · DI B829151
IOR — Wheelchair, Mechanical · Class I · 21 CFR 890.3850
UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
Initiated
Recall #
Class
Status
Reason
Link basis
2012-06-12
Z-2695-2014
Class II
Terminated
The hex bolt head might shear and cause the axle plate to detach from the lower frame of the wheelchair and could collapse the wheels while in use.
k number procode
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-04
0
1
2019-09
0
1
2019-12
0
1
2020-01
0
1
2020-05
0
1
2020-08
0
1
2020-09
0
1.2
2020-10
0
1
2020-12
0
1.33
2021-02
0
1
2021-03
0
1
2021-06
0
1.57
2021-07
0
2.5
2021-08
0
3.67
2021-09
0
1.25
2021-10
0
1.2
2021-12
0
2.5
2022-07
0
1
2022-08
0
3
2022-09
0
1.5
2022-10
0
1
2022-11
0
1
2022-12
0
1.71
2023-01
0
2.33
2023-02
0
1
2023-03
0
2.5
2023-04
0
1
2023-05
0
1
2023-06
0
4.6
2023-08
0
2.67
2023-09
0
1.5
2023-10
0
3.22
2023-11
0
1
2023-12
0
1
2024-02
0
1.5
2024-04
0
2.57
2024-05
0
2.2
2024-06
0
2
2024-07
0
3.33
2024-08
0
4.33
2024-09
0
5.33
2024-10
0
4.67
2024-11
0
6.6
2024-12
0
3.25
2025-01
0
3.33
2025-02
0
5.2
2025-03
0
4.5
2025-04
0
8
2025-05
0
5
2025-06
0
4
2025-07
0
2.78
2025-08
0
1.5
2025-10
0
1.4
2025-11
0
1.25
2025-12
0
1
2026-01
0
1
2026-02
0
2.33
2026-03
0
1
2026-04
0
2
2026-05
0
2.96
2026-06
0
2.85
This device (reports/month)Average device in IOR (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K063736 — cited as predicate by K113164, K130788, K152827
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — PDG Product Design Group Inc