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Therm-X

Model Therm-X Hand Garment · ZENITH TECHNICAL INNOVATIONS, LLC · DI 00850001096492

ILO — Pack, Hot Or Cold, Water Circulating · Class II · 21 CFR 890.5720

IRP — Massager, Powered Inflatable Tube · Class II · 21 CFR 890.5650

JOW — Sleeve, Limb, Compressible · Class II · 21 CFR 870.5800

UDILibrary device dossier · generated 2026-09-07 · 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.

51014192019-01: 0 reports for this device; peer average 1.5/device2019-04: 0 reports for this device; peer average 1.67/device2019-05: 0 reports for this device; peer average 1.75/device2019-06: 0 reports for this device; peer average 2.5/device2019-07: 0 reports for this device; peer average 1.67/device2019-08: 0 reports for this device; peer average 3/device2019-09: 0 reports for this device; peer average 1.33/device2019-10: 0 reports for this device; peer average 1.6/device2019-11: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 19/device2020-02: 0 reports for this device; peer average 3.8/device2020-03: 0 reports for this device; peer average 1.5/device2020-07: 0 reports for this device; peer average 1.67/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 1.5/device2020-10: 0 reports for this device; peer average 1.5/device2020-11: 0 reports for this device; peer average 2/device2020-12: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 1.2/device2021-02: 0 reports for this device; peer average 2.33/device2021-03: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 1.17/device2021-05: 0 reports for this device; peer average 1.33/device2021-06: 0 reports for this device; peer average 2.67/device2021-07: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 2/device2022-03: 0 reports for this device; peer average 2.33/device2022-04: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1.5/device2022-06: 0 reports for this device; peer average 1.5/device2022-08: 0 reports for this device; peer average 4/device2022-09: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 4.67/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 2/device2023-06: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 2/device2023-09: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 4/device2023-11: 0 reports for this device; peer average 1.33/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 1.67/device2024-05: 0 reports for this device; peer average 1.6/device2024-06: 0 reports for this device; peer average 1.5/device2024-07: 0 reports for this device; peer average 2/device2024-10: 0 reports for this device; peer average 1/device2024-11: 0 reports for this device; peer average 2.67/device2024-12: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 4/device2025-02: 0 reports for this device; peer average 1.67/device2025-03: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1.75/device2025-08: 0 reports for this device; peer average 3/device2025-09: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 1/device2026-01: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 1.75/device2026-04: 0 reports for this device; peer average 6.67/device2026-05: 0 reports for this device; peer average 4.25/device2026-06: 0 reports for this device; peer average 2.83/device01040506070809101112020307080910111201020304050607080910110304050608091012010203040506070809101102030405060710111201020304070809100103040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.5
2019-0401.67
2019-0501.75
2019-0602.5
2019-0701.67
2019-0803
2019-0901.33
2019-1001.6
2019-1101
2019-12019
2020-0203.8
2020-0301.5
2020-0701.67
2020-0801
2020-0901.5
2020-1001.5
2020-1102
2020-1201
2021-0101.2
2021-0202.33
2021-0301
2021-0401.17
2021-0501.33
2021-0602.67
2021-0701
2021-0802
2021-0901
2021-1001
2021-1102
2022-0302.33
2022-0401
2022-0501.5
2022-0601.5
2022-0804
2022-0901
2022-1002
2022-1201
2023-0102
2023-0202
2023-0304.67
2023-0401
2023-0502
2023-0601
2023-0702
2023-0802
2023-0901
2023-1004
2023-1101.33
2024-0201
2024-0302
2024-0401.67
2024-0501.6
2024-0601.5
2024-0702
2024-1001
2024-1102.67
2024-1201
2025-0104
2025-0201.67
2025-0301
2025-0401
2025-0701.75
2025-0803
2025-0901
2025-1001
2026-0101
2026-0301.75
2026-0406.67
2026-0504.25
2026-0602.83
This device (reports/month)Average device in ILO, IRP, JOW (reports/device/month)

Regulatory clearances

  • K231912 SESE 2023-07-27 (k number procode)

Predicate lineage

K231912 — cites (transitively): K193550 (d1), K171685 (d2), K181149 (d2), K190854 (d2), K192114 (d2), K061866 (d3), K072620 (d3), K131327 (d3), K072666 (d4) — cited as predicate by K240125

K240125 — cites (transitively): K061866 (d1), K231912 (d1), K193550 (d2), K171685 (d3), K181149 (d3), K190854 (d3), K192114 (d3), K072620 (d4), K131327 (d4), K072666 (d5)

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

Manufacturer compliance record — ZENITH TECHNICAL INNOVATIONS, LLC

  • NAI 2024-03-21 Zenith Technical Innovations, LLC · 0 citations
  • NAI 2024-03-21 Zenith Technical Innovations, LLC · 0 citations
  • NAI 2021-06-16 Zenith Technical Innovations, LLC · 0 citations
  • NAI 2021-06-16 Zenith Technical Innovations, LLC · 0 citations