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Aspire
Model 01AS80 · Shenzhen XFT Medical Limited · DI 06970670070020
HCC — Device, Biofeedback · Class II · 21 CFR 882.5050
IPF — Stimulator, Muscle, Powered · Class II · 21 CFR 890.5850
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)
2019-02
0
1
2019-03
0
6
2019-06
0
2
2019-10
0
1.5
2019-11
0
4
2019-12
0
2
2020-02
0
2
2020-03
0
1
2020-06
0
2
2020-07
0
2
2020-09
0
2
2020-10
0
1
2020-11
0
1
2022-01
0
2
2022-06
0
2
2022-10
0
2
2023-05
0
1
2023-08
0
1
2023-09
0
1
2024-03
0
3.5
2024-06
0
1.5
2024-07
0
1
2025-05
0
2
2025-06
0
1
2025-12
0
2
2026-01
0
8
2026-02
0
1
This device (reports/month)Average device in HCC, IPF (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Shenzhen XFT Medical Limited