What is FDA product code PFO?

An active implantable bone conduction hearing system is a prescription device consisting of an implanted transducer, implanted electronics components, and an audio processor. The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone.

Ear Nose & Throat › ProstheticActive Implantable Bone Conduction Hearing System

Samba 2 BB User Kit, Right

Name: Samba 2 BB User Kit, right
Brand: Samba 2 BB User Kit, right

Catalogue number 52611, listed by Med-El Elektromedizinische Geräte Gesellschaft m.b.H., under Active Implantable Bone Conduction Hearing System. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Guangdong (2), Shanghai (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code PFO
Manufacturer	City	Province	Registered as	Device types
Jabil Circuit (Shanghai) Ltd.	Shanghai	Shanghai	Contract manufacturer	31
Mehow Innovative (Huizhou) Ltd.	Huizhou	Guangdong	Contract manufacturer	11
IN-Tech Electronics Ltd	Dongguan	Guangdong	Contract manufacturer	2

Record

Regulatory record for Samba 2 BB User Kit, right
Listed by	Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
FDA product code	PFO
Device type	Active Implantable Bone Conduction Hearing System
Device class	Class 2
Regulation	21 CFR 874.3340
Record published	2020-09-08
Record revised	2022-09-15 (version 3)

Specifications

Specifications
MRI safety	MR Unsafe
Prescription	Prescription only
Label carries	serial number
Storage	Handling environment humidity 10 to 90 % RH; Handling environment temperature -25 to 60 °C; Handling environment temperature -13 to 140 °F; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 10 to 90 % RH

Catalogue Numbers

Catalogue numbers for Samba 2 BB User Kit, right
Catalogue number	Size	Status
52611		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cochlear	Cochlear Ltd.	7
Sentio	Oticon Medical AB	7
Cochlear® Osia® 3 Sound Processor Magnet strength 4M	Cochlear Ltd.	5
Cochlear® Osia® 3(I) Sound Processor Magnet strength 4(I)	Cochlear Ltd.	5
Cochlear® Osia® Smart App	Cochlear Ltd.	2
Cochlear® Osia® Fitting Software 3	Cochlear Ltd.	2
Symfit 8.0 Download	Med-El Elektromedizinische Geräte Gesellschaft m.b.H.	2
BCI Bone Conduction Implant Kit	Med-El Elektromedizinische Geräte Gesellschaft m.b.H.	2
Cochlear® Osia® 3 Sound Processor Cover Mint	Cochlear Ltd.	1
Remote Control	Med-El Elektromedizinische Geräte Gesellschaft m.b.H.	1
Cochlear® Osia® 3(I) Sound Processor	Cochlear Ltd.	1
Samba 2 BB AP Unit, left	Med-El Elektromedizinische Geräte Gesellschaft m.b.H.	1

Showing 12 of 69. All products under Active Implantable Bone Conduction Hearing System

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.