Hokanson

A plethysmograph sensor that attaches to a plethysmograph instrument, used to measure volume changes in a limb or digit. The sensor has a tube filled with electrically resistive fluid…

Registry build 21.09.26

A plethysmograph sensor that attaches to a plethysmograph instrument, used to measure volume changes in a limb or digit. The sensor has a tube filled with electrically resistive fluid (indium-gallium), and is wrapped around the circumference of the limb or digit. The plethysmograph instrument measures the resistance changes of the sensor that occur when the resistive fluid column length changes according to circumference changes that occur with vascular flow changes.

2manufacturers in China registered for this device type
7catalogue numbers in this listing
5510(k) clearances naming this product code

Who Else Makes It

All of them in Guangdong.

Chinese manufacturers registered for FDA product code JOM
Manufacturer City Province Registered as Device types
Orantech Inc. Shenzhen Guangdong Contract manufacturer 40
Shenzhen Raycome Health Technology Co., Ltd. Shenzhen Guangdong Manufacturer 3

Record

Regulatory record for Hokanson
Listed by D. E. Hokanson, Inc., United States
FDA product code JOM
Device type Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device class Class 2
Regulation 21 CFR 870.2780
Establishment Contract manufacturer, Manufacturer
510(k) K982707
Record published 2016-09-09
Record revised 2024-01-03 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries manufacturing date, serial number
Packaging Pouch of 8, pouch of 7
Distribution end date 2017-08-31

Catalogue Numbers

Catalogue numbers for Hokanson
Catalogue number Size Status
EC6 In distribution
AI6 In distribution
Mercury Strain Gauge In distribution
RT2000 In distribution
Indium Gallium Strain Gauge In distribution
EC6 In distribution
AI6 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Dopplex Huntleigh Healthcare Ltd. 16
Medi Medi Manufacturing Inc 6
QuantaFlo Semler Scientific, Inc. 5
FloChec Semler Scientific, Inc. 3
Doppler Model 1059-C W/PPG Parks Medical Electronics, Inc. 2
TBL-ABI LD Technology LLC 1
SA-3000P Medicore Co., Ltd. 1
Mesi mTABLET ABI Mesi D.O.O. 1
Doppler Model 1050-C W/PPG Parks Medical Electronics, Inc. 1
Doppler Model 1058-C W/PPG Parks Medical Electronics, Inc. 1
Max Pulse Medicore Co., Ltd. 1
Doppler Model 1052-C Parks Medical Electronics, Inc. 1

Showing 12 of 20. All products under Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K023707 2003-02-12
K982707 1998-08-26
K883908 1988-10-28
K872517 1987-10-01
K801291 1980-07-08

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer