Analog Amplifier With Accessories
Analog Amplifier, 60 Hz with accessories - cable length 100 cm
6manufacturers in China registered for this device type
4catalogue numbers in this listing
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 | 2025-08-06 |
| Record revised | 2026-03-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Handling environment humidity 0 to 85 % RH; Storage environment humidity 0 to 85 % RH; Handling environment temperature -25 to 70 °C; Storage environment temperature -25 to 70 °C |
| Packaging | Box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AA03-60 | In distribution | |
| AA03-60 | In distribution | |
| AA03-60 | In distribution | |
| AA03-60 | In distribution |
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 |
| ThunderCell Battery | Bionit Labs Srl | 3 |
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.