Frame Runner
The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids without which they would not be able to run, who have sufficient awareness and perception of the…
The Ormesa Frame Runner is intended for children/adults who need mobility and balance aids without which they would not be able to run, who have sufficient awareness and perception of the space around them. It is suitable for people with severe motor and coordination difficulties who can use the Frame Runner as a therapeutic and recreational activity: its use improves fitness and strength as well as physical and emotional well-being. Even those who have difficulty controlling their balance while walking can benefit from the use of the Frame Runner thanks to the stability provided by the entire system.
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 | Ormesa SRL |
|---|---|
| FDA product code | ION |
| Device type | Exerciser, Non-Measuring |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5370 |
| Premarket notification | Exempt |
| Record published | 2025-09-20 |
| Record revised | 2026-07-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FRAME RUNNER MEDIUM FISS.2R26″1R24″ | In distribution | |
| FRAME RUNNER LARGE RIB.2R28″1R26″ | In distribution | |
| FRAME RUNNER LARGE RIB.2R24″1R26″ | In distribution | |
| FRAME RUNNER LARGE FISS.2R28″1R26″ | In distribution | |
| FRAME RUNNER LARGE FISS.2R26″1R24″ | In distribution | |
| FRAME RUNNER SMALL 3R20’’ | In distribution | |
| FRAME RUNNER LARGE RIB.2R26″1R24″ | In distribution | |
| FRAME RUNNER LARGE FISS.3R26″ | In distribution | |
| FRAME RUNNER LARGE RIB.3R28 | In distribution | |
| FRAME RUNNER MEDIUM RIB.2R24″1R20″ | In distribution | |
| FRAME RUNNER MEDIUM RIBALT.3R24 | In distribution | |
| FRAME RUNNER MEDIUM FISS.3R24″ | In distribution | |
| FRAME RUNNER LARGE FISS.3R24 | In distribution | |
| FRAME RUNNER MEDIUM RIB.2R26″1R24″ | In distribution | |
| FRAME RUNNER LARGE RIBALT.3R26 | In distribution | |
| FRAME RUNNER SMALL 2R24’’ 1R20’’ | In distribution | |
| FRAME RUNNER LARGE FISS.3R28 | In distribution | |
| FRAME RUNNER LARGE FISS.2R24″1R26″ | In distribution | |
| FRAME RUNNER LARGE RIB.3R24 | In distribution | |
| FRAME RUNNER MEDIUM FISS.2R24″1R20″ | 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 |
| 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 |
| 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.