OraStretch® Bitepad Pack – Standard
The OraStretch Bitepads are self-adhesive pads used with the OraStretch press device to cushion the user's teeth. This pack includes 4 edentulous sized bitepads.
82manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (28), Zhejiang (19), Jiangsu (12). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Foshan Huafukang Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 19 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Ningbo Hecai Medical Equipment Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 8 |
| Nantong Shunlong Physical Therapy Equipment Co., Ltd. | Rugao | Jiangsu | Contract manufacturer | 6 |
| Irest Health Science AND Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 5 |
| Taicang Jingquan Metal Products Co., Ltd. | Taicang | Jiangsu | Contract manufacturer | 4 |
| Changzhou Boer Plastic | Changzhou | Jiangsu | Contract manufacturer | 1 |
| Omould Technology China Co Ltd | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
Showing 12 of 82. All 82 manufacturers in China registered for Exerciser, Non-Measuring
Record
| Listed by | Cranio Mandibular Rehab, Inc. |
|---|---|
| FDA product code | ION |
| Device type | Exerciser, Non-Measuring |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5370 |
| Premarket notification | Exempt |
| Record published | 2024-04-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Width 60 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CR1050 | Width 60 mm | In distribution |
| CR1055 | Width 60 mm | In distribution |
| CR1057 | Width 60 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biko | Ormesa SRL | 81 |
| DeRoyal | Deroyal Industries, Inc. | 28 |
| McKesson | Mckesson Medical-Surgical Inc. | 23 |
| Frame Runner | Ormesa SRL | 20 |
| Performance Health | ASP Global, LLC | 18 |
| Flint Rehab | Flint Rehabilitation Devices, LLC | 9 |
| Myo Munchee | MYO Munchee (Operations) PTY Ltd | 6 |
| Drive | Drive DeVilbiss Healthcare | 6 |
| Putty Alimed Therapy Green Coded 2OZ | Alimed, LLC | 2 |
| Putty Alimed Therapy TAN Coded 2OZ | Alimed, LLC | 2 |
| Stairs CONVERTIBLE,4 6″ STEPS,6 4″ Steps | Hausmann Enterprises, LLC | 2 |
| Drivemedical | Drive DeVilbiss Healthcare | 2 |
Showing 12 of 231. All products under Exerciser, Non-Measuring
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.