Gentherm Medical, LLC

FDA Device Registration & Listing · Cincinnati, OH, US · Registration 1516825

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1516825
FEI Number
1516825
Entity Name
Gentherm Medical, LLC
City/State/Country
Cincinnati, OH, US
Establishment Address
12011 MOSTELLER RD, Cincinnati, OH 45241, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Gentherm Medical LLC (Owner Number: 1516825)
Owner / Operator Contact Address
12011 MOSTELLER RD., Cincinnati, OH 45241, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K232638
PMA Number
N/A

All Registered Proprietary Names

400CE 414CE IOB-010/IOB-010S Spinal Under Body Warming Blanket IOB-021/IOB-021S XL Upper Body Warming Blanket IOB-029/IOB-029S Lithotomy & Orthopedic Under Body Warming Blanket IOB-025/IOB-025S Infant Full Body & Under Body Warming Blanket IOB-012/IOB-012S Pediatric Lower Body Warming Blanket IOB-008/IOB-008S Full Body Surgical Warming Blanket IOB-006/IOB-006S Adult Under Body Warming Blanket IOB-304/IOB-304S Extra Large Size Warming Suit IOB-004/IOB-004S Full Body Warming Blanket IOB-007/IOB-007S Pediatric Full Body Warming Blanket IOB-001/IOB-001S Torso Warming Blanket IOB-027/IOB-027S Large Full Body Warming Blanket IOB-303/IOB-303S Large Size Warming Suit IOB-005/IOB-005S Pediatric Under Body Warming Blanket IOB-014/IOB-014S Pediatric Long Warming Blanket IOB-002/IOB-002S Lower Body Warming Blanket IOB-018/IOB-018S Multi-Access Warming Blanket IOB-302/IOB-302S Medium Size Warming Suit IOB-009/IOB-009S Large Pediatric Under Body Warming Blanket IOB-030/IOB-030S Multi-position Upper Body Warming Blanket IOB-020/IOB-020S Cardiac Access Warming Blanket IOB-028/IOB-028S Infant Under Body Warming Blanket IOB-019/IOB-019S Dual Port Torso Warming Blanket IOB-301/IOB-301S Small Size Warming Suit IOB-003/IOB-003S Upper Body Warming Blanket IOB-015/IOB-015S Cath Lab Warming Blanket IOB-016/IOB-016S Surgical Access Warming Blanket FilteredFlo Warming Blankets FF-244 FilteredFlo Warming Blankets FF-145 IOB-019/IOB-019S Dual Port Torso Warming Blanket IOB Temperature Management System IOB-507 IOB-021/IOB-021S XL Upper Body Warming Blanket IOB-303/IOB-303S Large Size Warming Suit IOB-010/IOB-010S Spinal Under Body Warming Blanket IOB-006/IOB-006S Adult Under Body Warming Blanket IOB-020/IOB-020S Cardiac Access Warming Blanket IOB-301/IOB-301S Small Size Warming Suit IOB-015/IOB-015S Cath Lab Warming Blanket IOB-008/IOB-008S Full Body Surgical Warming Blanket FilteredFlo Warming Blankets FF-247 IOB-029/IOB-029S Lithotomy & Orthopedic Under Body Warming Blanket IOB-002/IOB-002S Lower Body Warming Blanket IOB-012/IOB-012S Pediatric Lower Body Warming Blanket IOB-025/IOB-025S Infant Full Body & Under Body Warming Blanket FilteredFlo Warming Blankets FF-246 IOB-005/IOB-005S Pediatric Under Body Warming Blanket IOB-027/IOB-027S Large Full Body Warming Blanket IOB-304/IOB-304S Extra Large Size Warming Suit IOB-028/IOB-028S Infant Under Body Warming Blanket IOB-004/IOB-004S Full Body Warming Blanket IOB-030/IOB-030S Multi-position Upper Body Warming Blanket FilteredFlo Warming Blankets FF-442 FilteredFlo Warming Blankets FF-243 IOB-007/IOB-007S Pediatric Full Body Warming Blanket FilteredFlo Warming Blankets FF-248 IOB-302/IOB-302S Medium Size Warming Suit IOB-003/IOB-003S Upper Body Warming Blanket FilteredFlo Warming Blankets FF-344 IOB-016/IOB-016S Surgical Access Warming Blanket IOB-014/IOB-014S Pediatric Long Warming Blanket FilteredFlo Warming Blankets FF-443 IOB-009/IOB-009S Large Pediatric Under Body Warming Blanket IOB-001/IOB-001S Torso Warming Blanket IOB-018/IOB-018S Multi-Access Warming Blanket

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DWC Controller, Temperature, Cardiopulmonary Bypass Cardiovascular Class 2 870.4250 2013-04-04
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2023-07-18
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2013-04-04
ILO Pack, Hot Or Cold, Water Circulating Physical Medicine Class 2 890.5720 2014-10-10
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2024-01-30

Official Correspondent

Angie Gegner

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Gentherm Medical LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3010168054 Jiangmen Dacheng Medical Equipment Co., Ltd. Jiangmen Guangdong, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K001520 Alpha Omega, Inc. ALPHA OMEGA DUAL COOLER-HEATER 2000-11-22
K171373 3M Company 3M Bair Hugger Model 675 Total Temperature Management System 2017-10-10
K083336 Smiths Medical Asd, Inc. LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL 2009-06-03

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0035-2010 Cincinnati Sub-Zero Products Inc 2
WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.
Z-0035-2022 CardioQuip, LLC 2
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
Z-0036-2022 CardioQuip, LLC 2
CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
Z-0037-2022 CardioQuip, LLC 2
CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110
Z-0038-2022 CardioQuip, LLC 2
CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1516825. Last updated year: 2026. Please use registration number 1516825 when referencing this establishment in official correspondence.
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