Biko
Medical device intended for children/teens/adults who have knowledge of the space around them, who are able to pedal and who have minimal control of the head and trunk. In addition, upper…
Medical device intended for children/teens/adults who have knowledge of the space around them, who are able to pedal and who have minimal control of the head and trunk. In addition, upper extremity motor control is required to properly steer the handlebars. Even those who have difficulty controlling their balance during the journey will be able to benefit from the use of the tricycle thanks to the stability offered by the whole system.
82manufacturers in China registered for this device type
81catalogue 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 | 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 | 2025-01-31 |
| Record revised | 2026-07-24 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BIKO LARGE ROSSO DIFF.CAMBIOeCONTR. | In distribution | |
| BIKO MEDIUM BLU DIFF.RUOTA LIBERA | In distribution | |
| BIKO XL ROSSO DIFF.PIGN.FISS0 | In distribution | |
| BIKO MEDIUM BLU DIFF.CAMBIOeCONTROP | In distribution | |
| BIKO MEDIUM BLU DIFF.PIGN.FISSO | In distribution | |
| BIKO XL ROSSO PIGN.FISS0 | In distribution | |
| BIKO MEDIUM VERD.PIGN.FISS0 | In distribution | |
| BIKO XL BLU RUOTA LIBERA | In distribution | |
| BIKO MEDIUM VERD.864 DIFF.PIGN.FISS | In distribution | |
| BIKO MEDIUM VERD.RUOTA LIBERA | In distribution | |
| BIKO XL VERD.DIFF.PIGN.FISS0 | In distribution | |
| BIKO SMALL BLU PIGN.FISSO | In distribution | |
| BIKO XL BLU 864 DIFF.PIGN.FISS0 | In distribution | |
| BIKO MEDIUM BLU RUOTA LIBERA | In distribution | |
| BIKO LARGE VERD.DIFF.CAMBIOeCONTROP | In distribution | |
| BIKO SMALL ROSSO PIGN. FISSO | In distribution | |
| BIKO LARGE VERD.DIFF.PIGN.FISS0 | In distribution | |
| BIKO MEDIUM ROSSO 864 DIFF.PIG.FISS | In distribution | |
| BIKO MINI ROSA PIGN.FISS0 | In distribution | |
| BIKO MEDIUM VERD.DIFF.CAMBIOeCONTR. | In distribution | |
| BIKO MEDIUM ROSSO DIFF.CAMBIOeCONTR | In distribution | |
| BIKO LARGE BLU RUOTA LIBERA | In distribution | |
| BIKO LARGE BLU DIFF.PIGN.FISS0 | In distribution | |
| BIKO XL ROSSO 864 DIFF.RUOTA LIBERA | In distribution | |
| BIKO MEDIUM ROSSO DIFF.RUOTA LIBERA | In distribution | |
| BIKO MINI ROSA RUOTA LIBERA | In distribution | |
| BIKO XL ROSSO DIFF.CAMBIOeCONTROP | In distribution | |
| BIKO MINI BLU RUOTA LIBERA | In distribution | |
| BIKO MEDIUM BLU 864 DIFF.PIGN.FISS0 | In distribution | |
| BIKO SMALL BLU DIFF.RUOTA LIBERA | In distribution | |
| BIKO MEDIUM ROSSO RUOTA LIBERA | In distribution | |
| BIKO LARGE ROSSO PIGN.FISS0 | In distribution | |
| BIKO MEDIUM VERD.864 DIFF.RUOTA LIB | In distribution | |
| BIKO LARGE ROSSO 864 DIFF.PIGN.FISS | In distribution | |
| BIKO SMALL ROSA RUOTA LIBERA | In distribution | |
| BIKO LARGE BLU 864 DIFF.PIGN.FISS0 | In distribution | |
| BIKO LARGE ROSSO RUOTA LIBERA | In distribution | |
| BIKO MEDIUM ROSSO 864 DIFF.RUOT.LIB | In distribution | |
| BIKO LARGE ROSSO DIFF.PIGN.FISS0 | In distribution | |
| BIKO SMALL ROSA PIGN.FISS0 | In distribution | |
| BIKO XL ROSSO DIFF.RUOTA LIBERA | In distribution | |
| BIKO XL VERD.RUOTA LIBERA | In distribution | |
| BIKO LARGE ROSSO 864 DIFF.RUOTA LIB | In distribution | |
| BIKO XL VERD.PIGN.FISS0 | In distribution | |
| BIKO SMALL ROSSO DIFF.PIGN.FISS0 | In distribution | |
| BIKO XL VERD.864 DIFF.RUOTA LIBERA | In distribution | |
| BIKO SMALL BLU RUOTA LIBERA | In distribution | |
| BIKO SMALL BLU DIFF.PIGN.FISSO | In distribution | |
| BIKO LARGE VERD.RUOTA LIBERA | In distribution | |
| BIKO LARGE BLU PIGN.FISSO | In distribution | |
| BIKO MEDIUM VERD.DIFF.RUOTA LIBERA | In distribution | |
| BIKO SMALL ROSA DIFF.PIGN.FISS0 | In distribution | |
| BIKO MINI ROSSO RUOTA LIBERA | In distribution | |
| BIKO SMALL ROSSO RUOTA LIBERA | In distribution | |
| BIKO XL BLU DIFF.CAMBIOeCONTROP | In distribution | |
| BIKO MEDIUM BLU PIGN.FISS0 | In distribution | |
| BIKO XL ROSSO RUOTA LIBERA | In distribution | |
| BIKO LARGE BLU 864 DIFF.RUOTA LIBER | In distribution | |
| BIKO MEDIUM ROSSO PIGN.FISS0 | In distribution | |
| BIKO LARGE VERD.864 DIFF.RUOTA LIB. | In distribution | |
| BIKO LARGE VERD.864 DIFF.PIGN.FISS0 | In distribution | |
| BIKO MEDIUM VERD.DIFF.PIGN.FISS0 | In distribution | |
| BIKO SMALL ROSA DIFF.RUOTA LIBERA | In distribution | |
| BIKO XL VERD.DIFF.RUOTA LIBERA | In distribution | |
| BIKO XL ROSSO 864 DIFF.PIGN.FISSO | In distribution | |
| BIKO MEDIUM ROSSO DIFF.PIGN.FISS0 | In distribution | |
| BIKO XL BLU PIGN.FISS0 | In distribution | |
| BIKO XL BLU DIFF.PIGN.FISS0 | In distribution | |
| BIKO XL BLU 864 DIFF.RUOTA LIBERA | In distribution | |
| BIKO SMALL ROSSO DIFF.RUOTA LIBERA | In distribution | |
| BIKO MINI BLU PIGN. FISSO | In distribution | |
| BIKO LARGE VERD.PIGN.FISS0 | In distribution | |
| BIKO LARGE ROSSO DIFF.RUOTA LIBERA | In distribution | |
| BIKO LARGE BLU DIFF.CAMBIOeCONTROP | In distribution | |
| BIKO LARGE VERD.DIFF.RUOTA LIBERA | In distribution | |
| BIKO LARGE BLU DIFF.RUOTA LIBERA | In distribution | |
| BIKO XL BLU DIFF.RUOTA LIBERA | In distribution | |
| BIKO MEDIUM BLU 864 DIFF.RUOTA LIBE | In distribution | |
| BIKO XL VERD.864 DIFF.PIGN.FISS0 | In distribution | |
| BIKO MINI ROSSO PIGN. FISSO | In distribution | |
| BIKO XL VERD.DIFF.CAMBIOeCONTROP | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.