← Product Code [DWJ](/productcode/DWJ) · K252861 # Warming System (K252861) _Hangzhou Tappa Medical Technology Co., Ltd. · DWJ · Apr 7, 2026 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K252861 ## Device Facts - **Applicant:** Hangzhou Tappa Medical Technology Co., Ltd. - **Product Code:** [DWJ](/productcode/DWJ.md) - **Decision Date:** Apr 7, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.5900 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic, Pediatric ## Indications for Use The Warming System is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated. ## Device Story Forced air warming system comprising a Medical Warming Unit (TMS-W101) and disposable warming blankets; used in clinical settings to regulate patient body temperature or provide thermal comfort. Unit takes ambient air, heats it via internal heater, and delivers it through a hose to a disposable blanket; blanket distributes air via internal channels and perforations to the patient. Operated by clinicians via front-panel buttons; includes LCD display for temperature settings and fault codes. Safety features include audible/visual alarms and automatic heater shut-off if outlet temperature exceeds 50°C. Benefits include prevention/treatment of hypothermia and maintenance of normothermia during clinical procedures. ## Clinical Evidence No clinical data. Substantial equivalence supported by bench testing, including performance testing (temperature control, accuracy, protection, noise), electrical safety (IEC 60601-1, 60601-1-2, 60601-2-35), biocompatibility (ISO 10993 series), and sterility/packaging integrity (ASTM F1886, F2096, F1929, F88, USP <71>). ## Technological Characteristics Forced air warming unit with mobile trolley; heater power 1000VA. Disposable blankets made of non-woven fabric and PE film. Temperature settings: 32°C, 38°C, 43°C (±1°C). Features replaceable 0.2-micron air filter, LCD display, and hose locking mechanism. Complies with IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-8, 60601-2-35. Sterilization via unspecified method for sterile variants. ## Regulatory Identification A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature. ## Predicate Devices - IOB Temperature Management System ([K231596](/device/K231596.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION April 7, 2026 Hangzhou Tappa Medical Technology Co., Ltd. Na Ban Registration Specialist No. 225#, Chutian Road, Binjiang District, Hangzhou Hangzhou, China Re: K252861 Trade/Device Name: Warming System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: March 6, 2026 Received: March 6, 2026 Dear Na Ban: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K252861 - Na Ban Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). {2} K252861 - Na Ban Page 3 Sincerely, **Meaghan Erlewein -S** For Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural, and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K252861 | | | Device Name Warming System | | | Indications for Use (Describe) The Warming System is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated. | | | Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {4} K252861 # 510(k) Summary ## I. Submitter Hangzhou Tappa Medical Technology Co., Ltd. No. 225#, Chutian Road, Binjiang District, Hangzhou, China Contact person: Ms. Banna Tel.: +86-13985728517 E-mail: bann@tongpumed.com Preparation date: September 8th, 2025 ## II. Proposed Device Device Trade Name: Warming System Common name: system, thermal regulating Regulation Number: 21 CFR 870.5900 Regulatory Class: Class II Product code: DWJ Review Panel: Cardiovascular ## III. Predicate Devices 510(k) Number: K231596 Trade name: IOB Temperature Management System Common name: System, thermal regulating Classification: Class II Product Code: DWJ Manufacturer: IOB Medical Inc Page 1 of 9 {5} Page 2 of 9 ## IV. General description The Warming System is a forced air warming system which is comprise of a Medical Warming Unit and variety models of Disposable Warming Blankets. It is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated. ## Medical Warming Unit (TMS - W101) The Medical Warming Unit is composed of a Medical Warming Unit and a mobile trolley (optional accessory). The Medical Warming Unit has the function of physically warming the human body in vitro, achieving the goal of assisting in regulating human body temperature. It can also be used to provide patients thermal comfort when the conditions exist that may cause patients to become too cold. The Medical Warming Unit are suitable for both adult and pediatric patients. Its application part is a Disposable Warming Blanket. The operation panel of Medical Warming Unit fully considers human-computer interaction. It is located on the inclined surface of the device and is simply operated by buttons. The desired temperature can be selected by pressing different temperature buttons. In an emergency, the alarm will sound and the screen will flash and display a fault code. In the standby interface, the total running time of the device can be checked by pressing the call mode button (hidden button, under the product model character) and the 43°C button. ## Disposable Warming Blanket (Sterile or Non Sterile) The Warming System is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated. ## V. Indications for use The Warming System is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated. ## VI. Comparison of technological characteristics with the predicate devices The comparison and discussion between the subject device and the predicate devices are listed in below table: {6} Table 1 General Comparison | Characteristics | Proposed device | Predicate device (K231596) | Discussion | | --- | --- | --- | --- | | Trade name | Warming System | IOB Temperature Management System | / | | Classification Name | system, thermal regulating | system, thermal regulating | Same | | Product Code | DWJ | DWJ | Same | | Regulation Number | 21 CFR 870.5900 | 21 CFR 870.5900 | Same | | Indications for use | The Warming System is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated. | The IOB Temperature Management System Model IOB-507 is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated. | Same | | Temperature Settings | Average temperature at the end of the gas pipe: High temperature:43°C±1°C Medium temperature:38°C±1°C Low temperature:32°C±1°C | 43°C+/-2°C 38°C+/-2°C 32°C+/-2°C Ambient | Same | | System Power | 100VAC 50Hz/60Hz 12A 110VAC 50Hz/60Hz 13.5A 120VAC 50Hz/60Hz 14A 127VAC 50Hz/60Hz 15A | 110-120 V, 60 Hz, 14 A | Similar | | Heater Power | 1000VA(Nominal value) | 950 W | Similar | | Dimensions | 33cm Length *27.5cm width *33cm height | 29.5 x 22 x 22 cm | Similar | {7} Page 4 of 9 | Weight | 6.5kg | 5.4 kg | Similar | | --- | --- | --- | --- | | EMI/EMC Compliant | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2 | Same | | Forced Air Over Temperature | When the temperature of the outlet of the air pipe exceeds 50°C, the sound and light alarm will be turned on and the heating will stop. | Auto-shuts heater off at 47°C+/-2°C | Similar | | Hose with Secure Locking | Yes | Yes | Same | | Air Filter | Replaceable 0.2 micron | Replaceable 0.2 micron | Same | | Temperature Display | Front panel LCD display | Front panel LCD display | Same | Analysis 1 System Power Clinical warming performance remains consistent across all supported voltages. This difference does not impact safety or effectiveness. Analysis 2 Heater Power The device meet EC 60601-1 requirements, this minor difference does not affect safety or effectiveness. Analysis 3 Forced Air Over Temperature Testing demonstrates equivalent patient protection. This difference does not compromise safety or effectiveness. Table 2 General Comparison between Disposable Warming Blanket and the predicate device | Characteristics | Proposed device | Predicate device (K231596) | Discussion | | --- | --- | --- | --- | | Indications For Use | The Warming System is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated. | The IOB Warming Blankets are indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized | Same | {8} | | | increase in temperature is clinically indicated. | | | --- | --- | --- | --- | | Material Design | Consists of Non-woven fabric and PE film | Consists of two layers of nonwoven polypropylene fabric bonded to a fusion layer of polyethylene. The layers are bonded together to form a distribution network of air delivery channels. The warm air is distributed around the patient's body through the delivery channels and exits the blanket through a specially designed series of perforations in the patient side layer of the blanket. The distribution of air is designed to minimize temperature differences of delivered air at different blanket locations. | Same | | Shelf Life | 5 years | 3 years | Difference 1 | | Sterility | Non-sterile and sterile | Non-sterile and sterile | Same | | Blanket Dimensions (approximate) | WB-1101-R/WB-1101-N 210×100cm WB-1102-R/WB-1102-N 190X70cm WB-1103-R/WB-1103-N 200X100cm | IOB-001/IOB-001S 142×120cm IOB-002/IOB-002S 142×120cm IOB-003/IOB-003S 202×64cm IOB-004/IOB-004S 210×120cm | Similar | Page 5 of 9 {9} | WB-1104-R/WB-1104-N | IOB-005/IOB-005S 100×80cm | | --- | --- | | 150X100cm | IOB-006/IOB-006S | | WB-1105-R/WB-1105-N | 215×100cm | | 130X100cm | IOB-007/IOB-007S | | WB-1106-R/WB-1106-N | 170×100cm | | 130X100cm | IOB-008/IOB-008S | | WB-1107-R/WB-1107-N | 210×120cm | | 190X100cm | IOB-009/IOB-009S 160×80cm | | WB-1109-R/WB-1109-N | IOB-010/IOB-010S | | WB-1110-R/WB-1110-N | 215×100cm | | WB-1111-R/WB-1111-N | IOB-011/IOB-011S | | WB-1112-R/WB-1112-N | 200×100cm | | WB-1113-R/WB-1113-N | IOB-012/IOB-012S | | WB-1114-R/WB-1114-N | 142×100cm | | WB-1115-R/WB-1115-N | IOB-014/IOB-014S 122×64cm | | WB-1116-R/WB-1116-N | IOB-015/IOB-015S 192×74cm | | WB-1117-R/WB-1117-N | IOB-016/IOB-016S | | WB-1118-R/WB-1118-N | 210×120cm | | WB-1119-R/WB-1119-N | IOB-017/IOB-017S | | WB-1120-R/WB-1120-N | 215×100cm | | WB-1121-R/WB-1121-N | IOB-018/IOB-018S | | WB-1122-R/WB-1122-N | 210×120cm | | WB-1123-R/WB-1123-N | IOB-019/IOB-019S | | WB-1124-R/WB-1124-N | 109×102cm | | WB-1125-R/WB-1125-N | IOB-020/IOB-020S | | WB-1126-R/WB-1126-N | 142×120cm | | WB-1127-R/WB-1127-N | IOB-021/IOB-021S | | WB-1128-R/WB-1128-N | 230×100cm | | WB-1129-R/WB-1129-N | IOB-022/IOB-022S | | WB-1130-R/WB-1130-N | 210×120cm | | WB-1131-R/WB-1131-N | IOB-023/IOB-023S 162×74cm | | WB-1132-R/WB-1132-N | IOB-024/IOB-024S | | WB-1133-R/WB-1133-N | 180×100cm | Page 6 of 9 {10} Page 7 of 9 | | WB-1204-R/WB-1204-N 180X70cm WB-1205-R/WB-1205-N 210X100cm WB-1206-R/WB-1206-N 210X100cm WB-2201-R/WB-2201-N 100X90cm WB-2202-R/WB-2202-N 140X90cm | IOB-025/IOB-025S 120×80cm IOB-026/IOB-026S 120×80cm IOB-027/IOB-027S 220×120cm IOB-028/IOB-028S 100×100cm IOB-029/IOB-029S 200×100cm IOB-030/IOB-030S 198×80cm IOB-034/IOB-034S 140×64cm IOB-301/IOB-301S 230×100cm IOB-302/IOB-302S 280×100cm IOB-303/IOB-303S 330×120cm IOB-304/IOB-304S 384×120cm | | --- | --- | --- | Analysis 1 The shelf life has been verified. This difference does not compromise safety or effectiveness. VII. Non-Clinical Testing The device described in this summary, was tested and demonstrated to be in conformance with the following standards: Performance testing: The following tests were conducted on the Medical Warming Unit: Appearance Output temperature control Temperature control accuracy Nozzle temperature protection Temperature protection of air duct compartment Output pipeline length Noise {11} Time to reach the set temperature Safety Software function Labels and accompanying materials The following tests were conducted on the Disposable Warming Blanket: Appearance Dimensions Sterility Welding Strength In addition, combined use testing of the Medical Warming Unit and Disposable Warming Blanket was performed. ## Reprocessing, Sterility, and Shelf-Life ASTM F1886/F1886M-16 ASTM F2096-11 ASTM F1929-23 ASTM F88/F88-23 USP<71> ASTM F 1980 ## Biocompatibility testing Biocompatibility of the device was evaluated in accordance with the FDA guidance “Use of International Standard ISO 10993-1” The following testing was conducted: - ISO 10993-1 - ISO 10993-5 - ISO 10993-10 - ISO 10993-23 ## Software Guidance for Industry and Food and Drug Administration Staff-Content of Premarket Submissions for Device Software Functions. ## Electrical Safety and EMC - IEC 60601-1 - IEC 60601-1-2 - IEC 60601-4-2 Page 8 of 9 {12} Page 9 of 9 - IEC 60601-1-6 - IEC 60601-1-8 - IEC 60601-2-35 - IEC 61000-4-3 ## VIII. Clinical Testing No clinical study is included in this submission. ## IX. Conclusion The proposed device has the same indication for use and has similar design features and technological characteristic as the predicate device. Performance testing data demonstrates that the proposed device is as safe and as effective as the predicated device. Accordingly, the proposed device is substantially equivalent to the predicate device. --- **Source:** [https://fda.innolitics.com/device/K252861](https://fda.innolitics.com/device/K252861) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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