Mizzy Comfort Cushion
Head Strap (2 Per Bag)
29manufacturers in China registered for this device type
1catalogue number
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 | Keystone Industries, United States |
|---|---|
| FDA product code | BTK |
| Device type | Strap, Head, Gas Mask |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5560 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-11-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 6070155 | 2 | 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.