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BITS Motion Sensor

Model BITS-3355 · BIONESS INC. · DI 00815962020634

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

ISD — Exerciser, Measuring · Class II · 21 CFR 890.5360

PTY — Computerized Cognitive Assessment Aid, Exempt · Class II · 21 CFR 882.1470

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.

24572019-07: 0 reports for this device; peer average 1/device2021-07: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1/device2023-10: 0 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/device2025-09: 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 1.33/device2026-05: 0 reports for this device; peer average 1/device2026-06: 0 reports for this device; peer average 1/device070712101103090103040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0701
2021-0701
2021-1201
2023-1003
2023-1101
2024-0302
2025-0902
2026-0102.5
2026-0307
2026-0401.33
2026-0501
2026-0601
This device (reports/month)Average device in IKK, ISD, PTY (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — BIONESS INC.

  • NAI 2017-08-04 Bioness Inc · 0 citations
  • NAI 2013-04-30 Bioness Inc · 0 citations
  • NAI 2011-08-04 Bioness Inc · 0 citations