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"54"" WALKING BELT BLUE"

Model 08140542 · Bird & Cronin, LLC · DI 00610570187287

IKX — Aid, Transfer · Class I · 21 CFR 890.5050

UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

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.

4812162019-02: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 16/device2023-12: 0 reports for this device; peer average 4/device02080205121112
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0201
2019-0801
2020-0201
2020-0501
2021-1201
2023-11016
2023-1204
This device (reports/month)Average device in IKX (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Bird & Cronin, LLC

Nothing in the loaded window.