Pediatric Headstrap
The Truer Medical Head Strap features two sleek designs to accommodate adult and child sizes which provide an even distribution of pressure to ensure maximum comfort. With minimal spacing…
The Truer Medical Head Strap features two sleek designs to accommodate adult and child sizes which provide an even distribution of pressure to ensure maximum comfort. With minimal spacing between the holes on the straps, these designs allow for a wide range of locations to secure the straps to any sized individual.
Who Else Makes It
Concentrated in Jiangsu (12), Guangdong (7), Zhejiang (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Fortune Company Ltd. | Huizhou | Guangdong | Contract manufacturer | 23 |
| Medex Medical Supplies Ltd. | China | Guangdong | Contract manufacturer | 20 |
| Tops Medical Articles Industries Nantong Inc | Qidong | Jiangsu | Contract manufacturer | 17 |
| Suzhou Minhua Medical Equipment Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Changzhou Meiguan Care Products Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 32 |
| Dongguan Hong De Medical Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
Showing 12 of 29. All 29 manufacturers in China registered for Strap, Head, Gas Mask
Record
| Listed by | Truer Medical, Inc., United States |
|---|---|
| FDA product code | BTK |
| Device type | Strap, Head, Gas Mask |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5560 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-06-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 90518 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Chin Strap | Sunset Healthcare Solutions, Inc. | 23 |
| AirLife™ | Airlife, Inc. | 7 |
| Rusch | Teleflex Medical LLC | 7 |
| Hudson RCI | Teleflex Medical LLC | 6 |
| Headgear | Sunset Healthcare Solutions, Inc. | 5 |
| Headgear | Suzhou Yuyue Medical Technology Co., Ltd. | 4 |
| Carex Health Brands | Drive DeVilbiss Healthcare | 3 |
| CPAP Headgear | Sunset Healthcare Solutions, Inc. | 3 |
| OTI | Xiamen OTI Electronic Industry Co., Ltd. | 2 |
| Strap, Head, Gas Mask | VBM Medizintechnik Gmbh | 2 |
| CPAP Masks | Sunset Healthcare Solutions, Inc. | 2 |
| CPAP Chinstrap | Pepper Medical, Inc. | 2 |
Showing 12 of 59. All products under Strap, Head, Gas Mask
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.