AIV
Fetal Transducer Coro Toco Button
2manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
Record
| Listed by | American IV Products, Inc. |
|---|---|
| FDA product code | HFM |
| Device type | Monitor, Uterine Contraction, External (For Use In Clinic) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.2720 |
| 510(k) | K040392 |
| Record published | 2016-09-02 |
| Record revised | 2022-11-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 14 to 140 °F |
| Sizes | Length 122.75 in; height 0.8 in; outer diameter 2.75 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FM10839 | Length 122.75 in | In distribution |
| FM10841 | Length 122.75 in | In distribution |
| FM10840 | Length 122.75 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Featherlite Toco | Parker Hannifin Corp. | 8 |
| Featherlite Toco Plus | Parker Hannifin Corp. | 4 |
| Featherlite Aqua | Parker Hannifin Corp. | 2 |
| Avalon Toco MP Transducer | Philips Medizin Systeme Böblingen GmbH | 2 |
| Monitor, Uterine Contraction, External (For Use In Clinic) | Wipro GE Healthcare Private Ltd. | 2 |
| Koala Toco® | Clinical Innovations, LLC | 1 |
| Toco Transducer | Wipro GE Healthcare Private Ltd. | 1 |
| Avalon CL Toco+ MP Transducer | Philips Medizin Systeme Böblingen GmbH | 1 |
| Avalon Toco+ Transducer | Philips Medizin Systeme Böblingen GmbH | 1 |
| Avalon Fetal & Maternal Patch | Philips Medical Systems Hsg | 1 |
| Avalon CL Fetal & Maternal Pod | Philips Medizin Systeme Böblingen GmbH | 1 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P890063 | 1990-09-12 | GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM | Matria Healthcare, Inc. |
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.