Who else makes this device?

Name: Avalon CL Fetal & Maternal Pod
Brand: Avalon CL Fetal & Maternal Pod

Obstetrics & Gynecology › MonitoringMonitor, Uterine Contraction, External (For Use In Clinic)

Avalon CL Fetal & Maternal Pod

The Avalon CL Fetal & Maternal Pod enables the Avalon wearable solution. It is used together with the Avalon CL Basestation 866074.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

All of them in Guangdong.

Chinese manufacturers registered for FDA product code HFM
Manufacturer	City	Province	Registered as	Device types
Edan Instruments, Inc.	Shenzhen	Guangdong	Contract manufacturer	56
Orantech Inc.	Shenzhen	Guangdong	Contract manufacturer	40

Record

Regulatory record for Avalon CL Fetal & Maternal Pod
Listed by	Philips Medizin Systeme Böblingen GmbH, Germany
FDA product code	HFM
Device type	Monitor, Uterine Contraction, External (For Use In Clinic)
Device class	Class 2
Regulation	21 CFR 884.2720
Record published	2020-05-22
Record revised	2026-01-15 (version 6)

Specifications

Specifications
MRI safety	MR Unsafe
Prescription	Prescription only
Label carries	serial number
Storage	Storage environment temperature -20 to 60 °C; Storage environment temperature -4 to 140 °F; Storage environment atmospheric pressure 57 to 106 KiloPascal; Storage environment humidity 15 to 90 % RH

Catalogue Numbers

Catalogue numbers for Avalon CL Fetal & Maternal Pod
Catalogue number	Size	Status
Avalon CL Fetal & Maternal Pod		In distribution

Same Product Code

Other products under the same FDA 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
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

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.

FDA premarket approvals naming this product code
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.