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"ThermoTek WRAP, KNEE, ROM BRACE, XL, 13"""
Model 0P9BRMLX13-XL · THERMOTEK, INC. · DI 00850033615197
ILO — Pack, Hot Or Cold, Water Circulating · Class II · 21 CFR 890.5720
ITQ — Joint, Knee, External Brace · Class I · 21 CFR 890.3475
JOW — Sleeve, Limb, Compressible · Class II · 21 CFR 870.5800
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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
1.5
2019-04
0
1.67
2019-05
0
1.75
2019-06
0
2.5
2019-07
0
1.67
2019-08
0
3.4
2019-09
0
1.33
2019-10
0
1.6
2019-11
0
1
2019-12
0
19
2020-02
0
3.8
2020-03
0
1.5
2020-07
0
1.67
2020-08
0
1
2020-09
0
1.5
2020-10
0
1.5
2020-11
0
2
2020-12
0
1
2021-01
0
1.2
2021-02
0
2.33
2021-03
0
1
2021-04
0
1.2
2021-05
0
1.33
2021-06
0
3
2021-07
0
1
2021-08
0
2
2021-09
0
1
2021-10
0
1
2021-11
0
2
2022-03
0
2.33
2022-04
0
1
2022-05
0
1.5
2022-06
0
1.5
2022-08
0
4
2022-09
0
1
2022-10
0
2
2022-12
0
1
2023-01
0
2
2023-02
0
2
2023-03
0
4.67
2023-04
0
1
2023-05
0
2
2023-06
0
1
2023-07
0
2
2023-08
0
2
2023-09
0
1
2023-10
0
4
2023-11
0
1.33
2024-02
0
1
2024-03
0
2
2024-04
0
1.67
2024-05
0
1.5
2024-06
0
1.5
2024-07
0
2
2024-08
0
2
2024-09
0
2
2024-10
0
1
2024-11
0
2.4
2024-12
0
1
2025-01
0
2
2025-02
0
1.67
2025-03
0
1
2025-04
0
1
2025-07
0
2
2025-08
0
3
2025-09
0
1
2025-10
0
1
2026-01
0
1
2026-03
0
1.75
2026-04
0
6.67
2026-05
0
4.25
2026-06
0
2.83
This device (reports/month)Average device in ILO, ITQ, JOW (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K061866 — cited as predicate by K103187, K103247, K111748, K122640, K162481, K171685, K181149, K190854, K223541, K240125, K252396, K253150
Lineage extracted from public 510(k) summary text (heuristic).