Monitor, Uterine Contraction, External (For Use in Clinic)
2 catalogue numbers from ULTRASOUND TRANSDUCER WATERTIGHT LOOP, listed by Wipro GE Healthcare Private Ltd., India, under Monitor, Uterine Contraction, External (For Use In Clinic). 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
2catalogue 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 | Wipro GE Healthcare Private Ltd., India |
|---|---|
| FDA product code | HFM |
| Device type | Monitor, Uterine Contraction, External (For Use In Clinic) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.2720 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K982651 |
| Record published | 2016-06-24 |
| Record revised | 2026-01-30 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 0 to 95 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -10 to 55 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ULTRASOUND TRANSDUCER WATERTIGHT LOOP | In distribution | |
| TOCO TRANSDUCER WATERTIGHT LOOP | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Featherlite Toco | Parker Hannifin Corp. | 8 |
| Featherlite Toco Plus | Parker Hannifin Corp. | 4 |
| AIV | American IV Products, Inc. | 3 |
| Featherlite Aqua | Parker Hannifin Corp. | 2 |
| Avalon Toco MP Transducer | Philips Medizin Systeme Böblingen GmbH | 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.