ThunderCell Battery Lamination Kit
Catalogue number MKEB01, listed by Bionit Labs Srl, Italy, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (3), Shanghai (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Fortune Company Ltd. | Huizhou | Guangdong | Contract manufacturer | 23 |
| AID United International Co., Limited | Shanghai | Shanghai | Specification developer | 65 |
| Yangzhou Sensport Healthcare Supplies Co., Ltd. | Yangzhou | Jiangsu | Manufacturer | 27 |
| Foshan Hongfeng Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 24 |
| Medex Medical Supplies Ltd. | China | Guangdong | Contract manufacturer | 20 |
| Oymotion Technologies Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
Record
| Listed by | Bionit Labs Srl, Italy |
|---|---|
| FDA product code | IQZ |
| Device type | Hand, External Limb Component, Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3420 |
| Premarket notification | Exempt |
| Record published | 2024-08-09 |
| Record revised | 2025-05-22 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Handling environment humidity 0 to 85 % RH; Handling environment temperature -20 to 70 °C; Storage environment humidity 0 to 85 % RH; Storage environment temperature -20 to 70 °C |
| Distribution end date | 2025-01-07 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MKEB01 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Adam’s Skin | Bionit Labs Srl | 51 |
| MYO | Hugh Steeper Ltd | 51 |
| Glide | Infinite Biomedical Technologies, LLC | 21 |
| Adam’s Hand | Bionit Labs Srl | 16 |
| Battery System | Hugh Steeper Ltd | 13 |
| S-Charge | Hugh Steeper Ltd | 11 |
| Electrode | Hugh Steeper Ltd | 9 |
| Harness Pavlik Type | Alimed, LLC | 5 |
| Zeus | Aether Biomedical SP. Z O.O. | 4 |
| Adam’s Hand – Loaner | Bionit Labs Srl | 4 |
| Esper Bionics | Esper, TOV | 4 |
| Analog Amplifier with accessories | Bionit Labs Srl | 4 |
Showing 12 of 68. All products under Hand, External Limb Component, Powered
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.