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COUNTER TOP BLANKET / FLUID WARMER Overall Size 30”W x 26.5”D x24.5”T

Model FHCSWC24-TL-MS · FUTURE HEALTH CONCEPTS, INC. · DI B337FHCSWC24TLMS1

LHC — Warmer, Irrigation Solution · Class I · 21 CFR 890.5950

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.

12232021-09: 0 reports for this device; peer average 3/device2024-09: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1/device090910
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-0903
2024-0901
2024-1001
This device (reports/month)Average device in LHC (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — FUTURE HEALTH CONCEPTS, INC.

  • VAI 2017-11-17 Future Health Concepts, Inc. · 4 citations
  • VAI 2017-11-17 Future Health Concepts, Inc. · 4 citations
  • VAI 2012-10-18 Future Health Concepts, Inc. · 3 citations
  • VAI 2012-10-18 Future Health Concepts, Inc. · 3 citations