TheraBite Range of Motion Scale (150 Pcs)
The Range of Motion Scale is used to monitor the progress of the jaw motion rehabilitation program. The TheraBite Jaw Motion Rehabilitation System is indicated for individuals who have, or…
The Range of Motion Scale is used to monitor the progress of the jaw motion rehabilitation program. The TheraBite Jaw Motion Rehabilitation System is indicated for individuals who have, or are at risk of developing trismus, (restrictions in their ability to open their jaw), and/or experience pain in the joints and/or muscles of the jaw. The device can also be used as a rehabilitation tool for postoperative physical therapy of the jaw, or to maintain the mouth open in a stable position, for example while performing dysphagia exercises.
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 | Atos Medical AB, Sweden |
|---|---|
| FDA product code | ION |
| Device type | Exerciser, Non-Measuring |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5370 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-11-29 |
| Record revised | 2024-11-25 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 36 to 108 °F; Special storage condition: Keep away from rain. Keep away from sunlight.; Storage environment temperature 2 to 42 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SC001 | 150 | 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 |
| OraStretch® Bitepad Pack → Standard | Cranio Mandibular Rehab, Inc. | 3 |
| 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 |
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.