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AUTOSOUND
Model 400-021 · Drive Devilbiss Healthcare · DI 00852515007049
GZJ — Stimulator, Nerve, Transcutaneous, For Pain Relief · Class II · 21 CFR 882.5890
IMG — Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat · Class II · 21 CFR 890.5860
IMI — Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat · Class II · 21 CFR 890.5300
IPF — Stimulator, Muscle, Powered · Class II · 21 CFR 890.5850
LIH — Interferential Current Therapy · Class II · 21 CFR 882.5890
UDILibrary device dossier · generated 2026-09-16 · 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)
2019-02
0
1
2019-06
0
2.5
2019-07
0
2
2019-08
0
2
2019-09
0
2
2019-10
0
1.2
2019-11
0
4
2019-12
0
1.67
2020-02
0
1.75
2020-03
0
2
2020-04
0
4
2020-06
0
2
2020-07
0
1.5
2020-09
0
2
2020-10
0
1
2020-11
0
1
2020-12
0
1.5
2021-02
0
1
2021-03
0
2
2021-04
0
2
2021-12
0
2
2022-01
0
2
2022-02
0
1.5
2022-03
0
2.8
2022-05
0
2
2022-06
0
2
2022-08
0
2
2022-09
0
2
2022-10
0
2
2023-01
0
2
2023-02
0
2
2023-04
0
1
2023-05
0
1
2023-06
0
2
2023-07
0
3
2023-08
0
1
2023-09
0
1
2023-11
0
2
2023-12
0
4
2024-01
0
5
2024-02
0
2
2024-03
0
3.5
2024-04
0
3.4
2024-05
0
2
2024-06
0
1.67
2024-07
0
2
2024-08
0
2
2024-10
0
1
2025-02
0
1.25
2025-03
0
1
2025-04
0
2
2025-05
0
2.67
2025-06
0
1
2025-07
0
2
2025-08
0
1.33
2025-09
0
1.5
2025-10
0
1
2025-12
0
1.5
2026-01
0
8
2026-02
0
1
2026-05
0
2.5
2026-06
0
1
This device (reports/month)Average device in GZJ, IMG, IMI, IPF, LIH (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Drive Devilbiss Healthcare
Warning Letter 2021-11-23 DeVilbiss Healthcare LLC
Warning Letter 2012-10-10 Drive DeVilbiss Healthcare
NAI 2024-05-30 DeVilbiss Healthcare LLC · 0 citations