PRO-Diary
PRO-Diary is a body-worn recorder that combines physical activity monitoring with an electronic patient diary. An accelerometer measures limb or torso movement during daily living and…
PRO-Diary is a body-worn recorder that combines physical activity monitoring with an electronic patient diary. An accelerometer measures limb or torso movement during daily living and sleep, while the wearer enters responses to programmed questions.
The compact battery-powered unit stores movement counts and diary entries in internal memory. Its display and score pad provide the subjective input function, distinguishing it from an activity recorder alone.
Listed Item
Ambulatory Physical Activity Recorder with Electronic Patient diary
Data Workflow
Healthcare providers use computer software to configure the recorder, download data and analyze activity offline. A USB connection transfers information to the computer. Diary responses can supplement or replace a written patient diary alongside the movement record.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Fenda Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
Record
| Listed by | Camntech, United Kingdom |
|---|---|
| FDA product code | LEL |
| Device type | Device, Sleep Assessment |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5050 |
| Establishment | Manufacturer |
| 510(k) | K132764 |
| Record published | 2019-08-29 |
| Record revised | 2020-03-05 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PDV | In distribution | |
| PDM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Braebon Ultima Body Position Sensor | Braebon Medical Corp. | 5 |
| EmbraceMini | Empatica SRL | 2 |
| Braebon Ultima Body Position Sensor for Alice 5 | Braebon Medical Corp. | 2 |
| MotionWatch | Camntech | 2 |
| ActiGraph | ActiGraph L.L.C. | 2 |
| Neurovirtual | Neurovirtual USA, Inc. | 1 |
| Actiwave | Camntech | 1 |
| EasyNet | Cadwell Industries, Inc. | 1 |
| Braebon Ultima Body Position Sensor with 2.5 mm phone connector | Braebon Medical Corp. | 1 |
| Oxevision Sleep system | Oxehealth Ltd | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K132764 | 2014-01-21 |
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.