Chalgren
Detachable Monopolar Needle Electrode, EMG, 44mm x 27ga
2manufacturers in China registered for this device type
42catalogue numbers in this listing
9510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Shandong (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| BIO Protech Yantai Inc | Yantai | Shandong | Manufacturer | 12 |
Record
| Listed by | Chalgren Enterprises, Inc., United States |
|---|---|
| FDA product code | IKT |
| Device type | Electrode, Needle, Diagnostic Electromyograph |
| Device class | Class 2 |
| Regulation | 21 CFR 890.1385 |
| 510(k) | K912283 |
| Record published | 2016-09-09 |
| Record revised | 2019-08-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10, box of 20, box of 25, box of 50, box of 12, box of 35 |
| Sizes | Needle gauge 23 to 30 G |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 242-025-24TP-1 | Needle Gauge 30 G | In distribution |
| 221-28SS-730 | Needle Gauge 27 G | In distribution |
| 242-637-24TP-1 | Needle Gauge 26 G | In distribution |
| 221-222SS-535 | In distribution | |
| 111-637-24TP | Needle Gauge 26 G | In distribution |
| 221-18SS-550 | Needle Gauge 25 G | In distribution |
| 110-637 | Needle Gauge 26 G | In distribution |
| 110-744 | Needle Gauge 27 G | In distribution |
| 111-4100-24TP | Needle Gauge 24 G | In distribution |
| 242-375-24TP-1 | Needle Gauge 23 G | In distribution |
| 125-412-36TP | Needle Gauge 24 G | In distribution |
| 111-737-24TP | Needle Gauge 27 G | In distribution |
| 242-725-24TP-1 | Needle Gauge 27 G | In distribution |
| 111-4125-24TP | Needle Gauge 24 G | In distribution |
| 115-725-29TP | Needle Gauge 27 G | In distribution |
| 111-575-24TP | Needle Gauge 25 G | In distribution |
| 111-650-24TP | Needle Gauge 26 G | In distribution |
| 111-837-24TP | Needle Gauge 28 G | In distribution |
| 221-28SS-375 | Needle Gauge 23 G | In distribution |
| 110-737 | Needle Gauge 27 G | In distribution |
| 115-650-29TP | Needle Gauge 26 G | In distribution |
| 115-820-29TP | Needle Gauge 28 G | In distribution |
| 110-650 | Needle Gauge 26 G | In distribution |
| 126-425-36TP | Needle Gauge 24 G | In distribution |
| 242-3125-24TP-1 | Needle Gauge 23 G | In distribution |
| 111-744-24TP | Needle Gauge 27 G | In distribution |
| 115-575-29TP | Needle Gauge 25 G | In distribution |
| 221-222SS-550-1 | Needle Gauge 25 G | In distribution |
| 221-222SS-730-1 | Needle Gauge 27 G | In distribution |
| 110-725-1 | Needle Gauge 25 G | In distribution |
| 111-737-8TP | Needle Gauge 27 G | In distribution |
| 125-425-36TP | Needle Gauge 24 G | In distribution |
| 221-18SS-730 | Needle Gauge 27 G | In distribution |
| 221-28SS-550 | Needle Gauge 25 G | In distribution |
| 115-737-29TP | Needle Gauge 27 G | In distribution |
| 242-3100-24TP-1 | Needle Gauge 23 G | In distribution |
| 111-725-24TP | Needle Gauge 27 G | In distribution |
| 110-725 | Needle Gauge 27 G | In distribution |
| 115-637-29TP | Needle Gauge 26 G | In distribution |
| 126-412-36TP | Needle Gauge 24 G | In distribution |
| 242-550-24TP-1 | Needle Gauge 25 G | In distribution |
| 121-812-24TP | Needle Gauge 28 G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Disposable EMG needle electrodes | Spes Medica Srl | 122 |
| Technomed Europe | Technomed Engineering B.V. | 92 |
| Cadwell | Technomed Engineering B.V. | 42 |
| Rhythmlink® | Rhythmlink International, LLC | 39 |
| Electrode, Needle, Diagnostic Electromyograph | Neurovision Medical Products, Inc. | 38 |
| MediMax Tech | Medimax Tech Inc. | 19 |
| Bio Protech | BIO Protech USA, Inc. | 19 |
| UltraPoint™ | Rochester Electro Medical, Inc. | 18 |
| Bionen | Bionen SAS DI Barbara Nencioni & C. | 17 |
| Natus Neurology | Natus Neurology Incorporated | 13 |
| Neuroguard | Technomed Engineering B.V. | 11 |
| Teca Elite | Natus Manufacturing Limited | 11 |
Showing 12 of 39. All products under Electrode, Needle, Diagnostic Electromyograph
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K982950 | 1999-06-22 |
| K960591 | 1996-06-13 |
| K955335 | 1996-01-29 |
| K953887 | 1995-10-31 |
| K953886 | 1995-10-31 |
| K931029 | 1994-08-25 |
| K924521 | 1993-02-12 |
| K912283 | 1992-03-16 |
| K912282 | 1992-03-16 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Closed |
|---|---|---|---|---|---|---|
| Chalgren Enterprises, Inc. | 510(k) number | 2007-04-12 | Not classified | Packaging | Sterility Compromised– Investigation found that individual packaging seals were separating, which may compromise sterility. | 2011-03-24 |
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.