Otomag™ Alpha (M) Magnetic Implant
Magnetic Implant S0521-01 Ster MRI Unsaf
4manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Henan (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Zdeer Technology (Henan) Co., Ltd. | Xuchang | Henan | Remanufacturer | 9 |
| Shenzen Magnet Technology Co., Ltd. | Shenzen | Guangdong | Manufacturer | 2 |
| Sonitus Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Specification developer | 1 |
Record
| Listed by | Medtronic Xomed, Inc., United States |
|---|---|
| FDA product code | LXB |
| Device type | Hearing Aid, Bone Conduction |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3302 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K102199 |
| Record published | 2016-04-15 |
| Record revised | 2024-05-22 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -20 to 50 °C |
| Distribution end date | 2023-12-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S0263-00 | Withdrawn | |
| S0263-01 | Withdrawn | |
| S0521-02 | Withdrawn | |
| S0521-01 | Withdrawn | |
| S0521-01 | Withdrawn | |
| S0521-02 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ponto | Oticon Medical AB | 172 |
| Hearing Aid, Bone Conduction | BHM-Tech Produktionsgesellschaft m.b.H. | 99 |
| Baha | Cochlear Bone Anchored Solutions AB | 98 |
| Otomag™ Attract™ Magnetic Spacer | Medtronic Xomed, Inc. | 23 |
| Attract™ | Medtronic Xomed, Inc. | 22 |
| Otomag™ Alpha 2 Sound Processor | Medtronic Xomed, Inc. | 21 |
| Hearing Aid, Bone Conduction | Medtronic Xomed, Inc. | 21 |
| contact | BHM-Tech Produktionsgesellschaft m.b.H. | 21 |
| contact mini | BHM-Tech Produktionsgesellschaft m.b.H. | 12 |
| contact forte Alpha | BHM-Tech Produktionsgesellschaft m.b.H. | 5 |
| contact forte | BHM-Tech Produktionsgesellschaft m.b.H. | 5 |
| Baha 5 SuperPower Actuator unit | Cochlear Bone Anchored Solutions AB | 4 |
Showing 12 of 230. All products under Hearing Aid, Bone Conduction
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.