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EMFACE controller
Model BTL-785-7 · BTL INDUSTRIES LIMITED · DI B108785APMMUS10
GEI — Electrosurgical, Cutting & Coagulation & Accessories · Class II · 21 CFR 878.4400
NFO — Stimulator, Transcutaneous Electrical, Aesthetic Purposes · Class II · 21 CFR 882.5890
NUW — Stimulator, Muscle, Powered, Dental · Class II · 21 CFR 890.5850
PBX — Massager, Vacuum, Radio Frequency Induced Heat · Class II · 21 CFR 878.4400
UDILibrary device dossier · generated 2026-09-11 · 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)
2019-01
0
6.78
2019-02
0
4.35
2019-03
0
4.42
2019-04
0
6.06
2019-05
0
4.8
2019-06
0
5.04
2019-07
0
5.86
2019-08
0
6.1
2019-09
0
4.99
2019-10
0
5.83
2019-11
0
5.62
2019-12
0
5.41
2020-01
0
4.81
2020-02
0
5.57
2020-03
0
5.68
2020-04
0
3.57
2020-05
0
3.76
2020-06
0
5.14
2020-07
0
6.56
2020-08
0
4.64
2020-09
0
5.86
2020-10
0
5.52
2020-11
0
5.14
2020-12
0
5.31
2021-01
0
5.17
2021-02
0
4.89
2021-03
0
5.68
2021-04
0
5.26
2021-05
0
5.12
2021-06
0
5.77
2021-07
0
4.86
2021-08
0
4.3
2021-09
0
4.77
2021-10
0
6.17
2021-11
0
5.57
2021-12
0
5.56
2022-01
0
5.04
2022-02
0
5.15
2022-03
0
5.75
2022-04
0
4.98
2022-05
0
5.75
2022-06
0
6.3
2022-07
0
4.36
2022-08
0
4.59
2022-09
0
5
2022-10
0
4.76
2022-11
0
4.61
2022-12
0
4.02
2023-01
0
5.52
2023-02
0
4.57
2023-03
0
4.85
2023-04
0
4.78
2023-05
0
5.11
2023-06
0
4.78
2023-07
0
4.82
2023-08
0
4.44
2023-09
0
5.23
2023-10
0
5.1
2023-11
0
4.36
2023-12
0
4.77
2024-01
0
5.52
2024-02
0
5.44
2024-03
0
6.13
2024-04
0
6.04
2024-05
0
6.25
2024-06
0
5.36
2024-07
0
5.05
2024-08
0
5.01
2024-09
0
5.18
2024-10
0
5.69
2024-11
0
5.27
2024-12
0
4.04
2025-01
0
5.17
2025-02
0
4.46
2025-03
0
6.26
2025-04
0
4.39
2025-05
0
5.12
2025-06
0
5.04
2025-07
0
5.18
2025-08
0
5.41
2025-09
0
4.81
2025-10
0
5.12
2025-11
0
5.49
2025-12
0
5.79
2026-01
0
5.6
2026-02
0
5.98
2026-03
0
6.18
2026-04
0
5.36
2026-05
0
6.17
2026-06
0
5.56
This device (reports/month)Average device in GEI, NFO, NUW, PBX (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — BTL INDUSTRIES LIMITED