Model BIT-3155 · Bioness Medical, Inc. · DI 00810188050045
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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-07
0
1
2021-07
0
1
2021-12
0
1
2023-10
0
3
2023-11
0
1
2024-03
0
2
2025-09
0
2
2026-01
0
2.5
2026-03
0
7
2026-04
0
1.33
2026-05
0
1
2026-06
0
1
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 Medical, Inc.