Konmed
It is a product can be used as medical purposes specified in Intended use and it is easy to wear and take off and with humanized design, which can be adjustableit is designed with below…
It is a product can be used as medical purposes specified in Intended use and it is easy to wear and take off and with humanized design, which can be adjustableit is designed with below feature: – Dual function, including separation fingers and training fingers – Aluminum alloy make good supporting – Extractable aluminum alloy is, for easy cleaning and adjustment – Velcro is vertical arrangementfor easy wearing
Who Else Makes It
Concentrated in Hubei (2), Jiangsu (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gauke (Hubei) Healthcare Co., Ltd. | Huanggang | Hubei | Contract manufacturer | 36 |
| Gauke International Trading Co., Ltd. | Wuhan | Hubei | Repacker / relabeller | 36 |
| Changzhou Meiguan Care Products Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 32 |
| Changzhou Major Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 31 |
Record
| Listed by | Shenzhen Konmed Technology Co., Ltd., China |
|---|---|
| FDA product code | LQX |
| Device type | Device, Finger-Sucking |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3475 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-01-24 |
| Record revised | 2021-02-05 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KM-W-40 | In distribution | |
| KM-W-35 | In distribution | |
| KM-W-41 | In distribution |
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.