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1BYONE
Model 725EU-0002 · 1BYONEPRODUCTS INC. · DI 00858069007016
NGX — Stimulator, Muscle, Powered, For Muscle Conditioning · Class II · 21 CFR 890.5850
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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-11
0
2
2020-03
0
3
2020-04
0
6
2021-01
0
1.13
2022-02
0
6
2022-07
0
1
2022-10
0
1
2022-12
0
2
2023-04
0
1
2023-05
0
1
2023-09
0
2
2024-02
0
1
2024-03
0
3
2025-03
0
2
2025-06
0
1
2025-07
0
1.5
2025-08
0
2.5
2025-09
0
1
2025-10
0
3.5
2025-11
0
4.67
2025-12
0
1.54
2026-01
0
1
2026-02
0
1
2026-03
0
4
2026-04
0
1
2026-06
0
4
This device (reports/month)Average device in NGX (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K153520 — cited as predicate by K162517, K192201
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — 1BYONEPRODUCTS INC.