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ARP POV SPORT

Model PRS · ARP MANUFACTURING LLC · DI M7570040000

NGX — Stimulator, Muscle, Powered, For Muscle Conditioning · 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.

23562019-11: 0 reports for this device; peer average 2/device2020-03: 0 reports for this device; peer average 3/device2020-04: 0 reports for this device; peer average 6/device2021-01: 0 reports for this device; peer average 1.13/device2022-02: 0 reports for this device; peer average 6/device2022-07: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 3/device2025-03: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1.5/device2025-08: 0 reports for this device; peer average 2.5/device2025-09: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 3.5/device2025-11: 0 reports for this device; peer average 4.67/device2025-12: 0 reports for this device; peer average 1.54/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 4/device2026-04: 0 reports for this device; peer average 1/device2026-06: 0 reports for this device; peer average 4/device1103040102071012040509020303060708091011120102030406
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-1102
2020-0303
2020-0406
2021-0101.13
2022-0206
2022-0701
2022-1001
2022-1202
2023-0401
2023-0501
2023-0902
2024-0201
2024-0303
2025-0302
2025-0601
2025-0701.5
2025-0802.5
2025-0901
2025-1003.5
2025-1104.67
2025-1201.54
2026-0101
2026-0201
2026-0304
2026-0401
2026-0604
This device (reports/month)Average device in NGX (reports/device/month)

Regulatory clearances

  • K093999 SESE 2010-08-10 (k number procode)

Predicate lineage

K093999 — cites (transitively): K060846 (d1), K893851 (d1) — cited as predicate by K191181

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

Manufacturer compliance record — ARP MANUFACTURING LLC

  • VAI 2019-08-29 ARP Manufacturing, LLC · 2 citations
  • VAI 2015-10-16 ARP Manufacturing, LLC · 0 citations
  • NAI 2011-11-28 ARP Manufacturing, LLC · 0 citations