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Apollo Quattro

Model APQ-10M · WEERO Co., Ltd. · DI 08809851470114

GZJ — Stimulator, Nerve, Transcutaneous, For Pain Relief · Class II · 21 CFR 882.5890

IPF — Stimulator, Muscle, Powered · Class II · 21 CFR 890.5850

IRT — Pad, Heating, Powered · Class II · 21 CFR 890.5740

PBX — Massager, Vacuum, Radio Frequency Induced Heat · Class II · 21 CFR 878.4400

QPZ — Contact Cooling For Skin Lesion Pain Relief · Class II · 21 CFR 878.4340

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.

13452019-01: 0 reports for this device; peer average 1/device2019-02: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1.5/device2019-05: 0 reports for this device; peer average 1.5/device2019-06: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 4/device2019-08: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 1.33/device2019-11: 0 reports for this device; peer average 4/device2019-12: 0 reports for this device; peer average 1.67/device2020-01: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1.5/device2020-03: 0 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 1.5/device2020-07: 0 reports for this device; peer average 2/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 1.33/device2021-01: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 1/device2021-07: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1.5/device2022-01: 0 reports for this device; peer average 2/device2022-02: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 2/device2022-04: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 2.5/device2022-07: 0 reports for this device; peer average 2/device2022-09: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 1.17/device2022-12: 0 reports for this device; peer average 1.2/device2023-01: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 1.33/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 3/device2024-04: 0 reports for this device; peer average 1.4/device2024-05: 0 reports for this device; peer average 1.6/device2024-06: 0 reports for this device; peer average 1.2/device2024-07: 0 reports for this device; peer average 5/device2024-08: 0 reports for this device; peer average 2/device2024-09: 0 reports for this device; peer average 1.67/device2024-10: 0 reports for this device; peer average 1.75/device2024-11: 0 reports for this device; peer average 1/device2024-12: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1/device2025-02: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 1.5/device2025-04: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 1.5/device2025-06: 0 reports for this device; peer average 1.5/device2025-07: 0 reports for this device; peer average 1.25/device2025-08: 0 reports for this device; peer average 1.5/device2025-09: 0 reports for this device; peer average 1.2/device2025-10: 0 reports for this device; peer average 1.33/device2025-11: 0 reports for this device; peer average 1.33/device2025-12: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 4.5/device2026-02: 0 reports for this device; peer average 1.67/device2026-03: 0 reports for this device; peer average 3.25/device2026-04: 0 reports for this device; peer average 2.5/device2026-05: 0 reports for this device; peer average 2.5/device2026-06: 0 reports for this device; peer average 1.25/device0102040506070809101112010203060708091011120102030405060709111201020304050607091012010203040508091112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0201
2019-0401.5
2019-0501.5
2019-0602
2019-0704
2019-0802
2019-0902
2019-1001.33
2019-1104
2019-1201.67
2020-0101
2020-0201.5
2020-0302
2020-0601.5
2020-0702
2020-0801
2020-0902
2020-1001
2020-1101
2020-1201.33
2021-0101
2021-0201
2021-0301
2021-0401
2021-0501
2021-0601
2021-0701
2021-0901
2021-1101
2021-1201.5
2022-0102
2022-0201
2022-0302
2022-0401
2022-0501
2022-0602.5
2022-0702
2022-0901
2022-1001.17
2022-1201.2
2023-0101
2023-0201
2023-0301.33
2023-0401
2023-0501
2023-0801
2023-0901
2023-1101
2023-1202
2024-0102
2024-0202
2024-0303
2024-0401.4
2024-0501.6
2024-0601.2
2024-0705
2024-0802
2024-0901.67
2024-1001.75
2024-1101
2024-1201
2025-0101
2025-0201
2025-0301.5
2025-0401
2025-0501.5
2025-0601.5
2025-0701.25
2025-0801.5
2025-0901.2
2025-1001.33
2025-1101.33
2025-1202
2026-0104.5
2026-0201.67
2026-0303.25
2026-0402.5
2026-0502.5
2026-0601.25
This device (reports/month)Average device in GZJ, IPF, IRT, PBX, QPZ (reports/device/month)

Regulatory clearances

  • K253542 SESE 2026-06-08 (k number procode)
  • K253261 SESE 2026-03-13 (k number procode)

Predicate lineage

K253261 — cites (transitively): K042301 (d1), K212253 (d1), K213294 (d1), K210492 (d2), K083008 (d2), K203006 (d2), K201260 (d3), K201150 (d3), K102461 (d4), K131362 (d4), K140926 (d4), K151273 (d4), K160329 (d4), K172302 (d4), K180189 (d4), K182325 (d4), K192695 (d4), K200947 (d4), K171398 (d4), K182392 (d4), K073572 (d5), K090221 (d5), K083461 (d5), K130501 (d5), K161480 (d5), K153568 (d5), K081365 (d5), K082451 (d5), K142438 (d5), K151019 (d5), K171593 (d5), K170810 (d5), K101510 (d6), K073227 (d6), K073229 (d6), K132373 (d6), K140400 (d6), K121302 (d6), K150035 (d6), K110754 (d6), K152133 (d6), K030281 (d6), K160193 (d6), K103128 (d7), K123589 (d7), K122845 (d7), K123307 (d7), K142093 (d7), K111859 (d7), K113860 (d7), K121251 (d7), K123865 (d7), K140584 (d7), K143564 (d7), K014165 (d8), K031003 (d8), K050325 (d8), K062549 (d8), K062996 (d8), K063729 (d8), K992869 (d8), K963826 (d8), K060390 (d8), K102235 (d8), K050438 (d8), K122742 (d8), K061113 (d8), K971214 (d8), K133837 (d8) — cited as predicate by K253542

K253542 — cites (transitively): K042301 (d1), K210877 (d1), K212253 (d1), K241433 (d1), K253261 (d1), K183450 (d2), K201285 (d2), K210492 (d2), K213294 (d2), K131362 (d3), K172302 (d3), K192249 (d3), K201150 (d3), K083008 (d3), K203006 (d3), K090221 (d4), K153568 (d4), K132284 (d4), K102461 (d4), K140926 (d4), K151273 (d4), K160329 (d4), K180189 (d4), K182325 (d4), K192695 (d4), K200947 (d4), K201260 (d4), K073572 (d5), K040662 (d5), K062354 (d5), K900519 (d5), K970426 (d5), K083461 (d5), K130501 (d5), K150035 (d5), K081365 (d5), K082451 (d5), K142438 (d5), K151019 (d5), K171593 (d5), K171398 (d5), K182392 (d5), K101510 (d6), K073227 (d6), K073229 (d6), K132373 (d6), K140400 (d6), K142093 (d6), K121302 (d6), K161480 (d6), K160193 (d6), K170810 (d6), K103128 (d7), K123589 (d7), K122845 (d7), K123307 (d7), K133837 (d7), K110754 (d7), K152133 (d7), K030281 (d7), K014165 (d8), K031003 (d8), K050325 (d8), K062549 (d8), K062996 (d8), K063729 (d8), K992869 (d8), K102235 (d8), K050438 (d8), K122742 (d8), K061113 (d8), K971214 (d8), K113810 (d8), K111859 (d8), K113860 (d8), K121251 (d8), K123865 (d8), K140584 (d8), K143564 (d8)

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — WEERO Co., Ltd.

  • VAI 2024-09-05 WEERO CO LTD · 2 citations
  • VAI 2024-09-05 WEERO CO LTD · 2 citations