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"ROLLER FOAM FULL ROLL 36"" LONG X 6"" WIDE ALIMED 3/CS"

Model 3171603 · ALIMED, INC. · DI 00733657290684

ION — Exerciser, Non-Measuring · Class I · 21 CFR 890.5370

UDILibrary device dossier · generated 2026-09-12 · 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.

12232019-04: 0 reports for this device; peer average 2/device2019-06: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 3/device2021-07: 0 reports for this device; peer average 2/device2021-12: 0 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1/device2023-04: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 2/device04060910110306071204120405
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0402
2019-0601
2019-0901
2019-1001
2019-1101
2020-0301
2021-0603
2021-0702
2021-1201
2022-0401
2022-1201
2023-0401
2025-0502
This device (reports/month)Average device in ION (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — ALIMED, INC.

  • VAI 2016-07-07 AliMed Corporation · 1 citations
  • VAI 2016-07-07 AliMed Corporation · 1 citations
  • NAI 2011-03-04 AliMed Corporation · 0 citations
  • NAI 2011-03-04 AliMed Corporation · 0 citations