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Actiwatch Spectrum Plus

Model Actiwatch Spectrum Plus, Japan · Respironics, Inc. · DI 00606959042049

IKK — System, Isokinetic Testing And Evaluation · Class II · 21 CFR 890.1925

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 (2)

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.

Malfunction: 2

24572021-07: 0 reports for this device; peer average 1/device2023-10: 2 reports for this device; peer average 3/device2023-11: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 2.5/device2026-03: 0 reports for this device; peer average 7/device2026-04: 0 reports for this device; peer average 1.5/device07101103010304
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-0701
2023-1023
2023-1101
2024-0302
2026-0102.5
2026-0307
2026-0401.5
This device (reports/month)Average device in IKK (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Respironics, Inc.

  • OAI 2023-02-14 Respironics, Inc. · 1 citations
  • NAI 2016-12-07 Respironics, Inc. · 0 citations
  • NAI 2015-01-28 Respironics, Inc. · 0 citations
  • NAI 2012-06-15 Respironics, Inc. · 0 citations
  • NAI 2010-09-01 Respironics, Inc. · 0 citations
  • NAI 2010-06-22 Respironics, Inc. · 0 citations