IOB
The IOB Temperature Management System combines a warming unit with patient blankets. The unit draws in ambient air through a 0.2 micron filter, warms the filtered air to a selected…
The IOB Temperature Management System combines a warming unit with patient blankets. The unit draws in ambient air through a 0.2 micron filter, warms the filtered air to a selected temperature, and sends it through the blanket.
The FDA filing describes the system for patients who need induced hyperthermia or a localized increase in temperature. Warm air travels through channels in the blanket and exits through perforations on its patient-facing side.
Temperature Delivery
The filing lists three warming-unit settings: 32°C, 38°C and 43°C. It says a thermistor at the hose connection to the blanket controls the selected temperature. The system can also deliver ambient-temperature air.
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Anhui (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Copious Intl., Inc. | Heyuan, Guangdong Province | Contract manufacturer | 11 | |
| Jiangyin Puremed | Jiangyin | Jiangsu | Contract manufacturer | 7 |
| Betacera Inc. | Suzhou | Jiangsu | Contract manufacturer | 3 |
| Shanghai Xodus Medical Company Limited | Shanghai | Shanghai | Specification developer | 25 |
| Hangzhou Tappa Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 3 |
| Jiangmen Dacheng Medical Equipment Co., Ltd. | Jiangmen | Guangdong | Contract manufacturer | 1 |
Record
| Listed by | Iob Medical, Inc., United States |
|---|---|
| FDA product code | DWJ |
| Device type | System, Thermal Regulating |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5900 |
| 510(k) | K162679 |
| Record published | 2022-03-21 |
| Record revised | 2022-05-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Case of 40, pack of 40, case of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IOB-003S | In distribution | |
| IOB-002 | In distribution | |
| IOB-001 | In distribution | |
| IOB-018 | In distribution | |
| IOB-008 | In distribution | |
| IOB-004 | In distribution | |
| IOB-028 | In distribution | |
| IOB-001S | In distribution | |
| IOB-015 | In distribution | |
| IOB-301S | In distribution | |
| IOB-010S | In distribution | |
| IOB-007S | In distribution | |
| IOB-303S | In distribution | |
| IOB-014S | In distribution | |
| IOB-021S | In distribution | |
| IOB-025S | In distribution | |
| IOB-030S | In distribution | |
| IOB-007 | In distribution | |
| IOB-005 | In distribution | |
| IOB-020S | In distribution | |
| IOB-016S | In distribution | |
| IOB-008S | In distribution | |
| IOB-304S | In distribution | |
| IOB-012 | In distribution | |
| IOB-029 | In distribution | |
| IOB-023S | In distribution | |
| IOB-026S | In distribution | |
| IOB-028S | In distribution | |
| IOB-022S | In distribution | |
| IOB-027 | In distribution | |
| IOB-016 | In distribution | |
| IOB-014 | In distribution | |
| IOB-018S | In distribution | |
| IOB-029S | In distribution | |
| IOB-024S | In distribution | |
| IOB-025 | In distribution | |
| IOB-505 | In distribution | |
| IOB-015S | In distribution | |
| IOB-006S | In distribution | |
| IOB-020 | In distribution | |
| IOB-301 | In distribution | |
| IOB-011 | In distribution | |
| IOB-302S | In distribution | |
| IOB-303 | In distribution | |
| IOB-011S | In distribution | |
| IOB-009S | In distribution | |
| IOB-030 | In distribution | |
| IOB-019S | In distribution | |
| IOB-005S | In distribution | |
| IOB-027S | In distribution | |
| IOB-010 | In distribution | |
| IOB-002S | In distribution | |
| IOB-012S | In distribution | |
| IOB-003 | In distribution | |
| IOB-009 | In distribution | |
| IOB-006 | In distribution | |
| IOB-304 | In distribution | |
| IOB-017S | In distribution | |
| IOB-302 | In distribution | |
| IOB-004S | In distribution | |
| IOB-021 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mistral-Air | The Surgical Company International B.V. | 114 |
| Bair Hugger™ | 3M Company | 99 |
| IOB | Jiangmen Dacheng Medical Equipment Co., Ltd. | 68 |
| 3M™ Bair Hugger™ | 3M Company | 61 |
| Cocoon | Care Essentials PTY Ltd | 59 |
| Soft Air | Adroit Medical Systems, Inc. | 56 |
| Level 1 | ICU Medical, Inc | 49 |
| System, Thermal Regulating | Hangzhou Tappa Medical Technology Co., Ltd. | 47 |
| PremierPro | Prestige Ameritech | 39 |
| Bair Paws™ | 3M Company | 30 |
| SourceMark | Sourcemark, LLC. | 25 |
| Kozee | Sourcemark, LLC. | 24 |
Showing 12 of 166. All products under System, Thermal Regulating
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232638 | 2023-10-24 |
| K231596 | 2023-06-30 |
| K221669 | 2022-12-27 |
| K190221 | 2019-10-25 |
| K162679 | 2017-04-28 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.