Who is the manufacturer of MOTION WATCH AND PRO-DIARY?

Camntech, Ltd. filed the 510(k) submission for MOTION WATCH AND PRO-DIARY (K132764).

What is the FDA product code for MOTION WATCH AND PRO-DIARY?

LEL. It is classified under 21 CFR 882.5050 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for MOTION WATCH AND PRO-DIARY?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MOTION WATCH AND PRO-DIARY?

Actiwatch® (K983533); Actiwatch-Score® (K991033).

Who can help prepare an FDA 510(k) submission like MOTION WATCH AND PRO-DIARY?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MOTION WATCH AND PRO-DIARY

K132764 · Camntech, Ltd. · LEL · Jan 21, 2014 · Neurology

Device Facts

Record ID	K132764
Device Name	MOTION WATCH AND PRO-DIARY
Applicant	Camntech, Ltd.
Product Code	LEL · Neurology
Decision Date	Jan 21, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5050
Device Class	Class 2

Intended Use

The MotionWatch and PRO-Diary are compact, lightweight, body-worn activity monitoring devices that may be used to document physical movement associated with applications in physiological monitoring. The devices are intended to monitor limb or body movements during daily living and sleep. The MotionWatch and PRO-Diary can be used to assess activity in any instance where quantifiable analysis of physical motion is desired. Additionally, the PRO-Diary has a built-in score pad that allows the wearer to subjectively assign and enter responses to pre-programmed questions. The score pad can be used as a substitute or in addition to the traditional written patient diary in conjunction with activity monitoring.

Device Story

Compact, wrist-worn, battery-operated activity recorders; utilize solid-state accelerometers to measure limb/torso movement. MotionWatch includes ambient light sensor; PRO-Diary includes OLED display/score-pad for subjective patient input. Devices sample acceleration (1-3 axes) at 50Hz; process data into 'counts' stored in non-volatile memory. Used in clinical or home settings; operated by patients (wearable) and healthcare providers (configuration/data download via USB to PC). Healthcare providers use proprietary software to download, store, and analyze activity data. Output provides quantifiable physical motion analysis; PRO-Diary output includes subjective patient responses. Enables objective assessment of circadian rhythms, sleep parameters, and physical activity levels; replaces/supplements traditional written patient diaries.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified via bespoke tests: linear acceleration accuracy (+/-5%), frequency response (3-11 Hz), zero-count output during inactivity, light sensor accuracy, and data integrity during power resets. Safety and EMC testing conducted per IEC 60601-1, IEC 60601-1-11, and IEC 60601-1-2.

Technological Characteristics

Materials: Polycarbonate/ABS casing, nylon wrist band with stainless steel buckle. Sensing: Solid-state accelerometer (1, 2, or 3 axes). Sampling: 50 Hz raw rate; user-selectable epochs (1s to 1m). Connectivity: USB for PC data download. Power: CR2032 battery (MotionWatch) or rechargeable (PRO-Diary). Memory: 512KB (MotionWatch) or 4MB (PRO-Diary). Software: PC-based configuration and analysis. Sterilization: None required.

Indications for Use

Indicated for patients requiring monitoring of limb or body movements during daily living and sleep for physiological assessment. No specific age or gender contraindications stated.

Regulatory Classification

Identification

A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.

Predicate Devices

Actiwatch® (K983533)
Actiwatch-Score® (K991033)

Related Devices

K181077 — ActiGraph CentrePoint Insight Watch · Actigraph · May 24, 2018
K983533 — ACTIWATCH · Mini-Mitter Co., Inc. · Mar 23, 1999
K231532 — ActiGraph LEAP activity monitor (ActiGraph LEAP) · Actigraph, LLC · Jun 23, 2023
K233987 — VERABAND · Arbor Medical Innovations, LLC · Jun 17, 2024
K991033 — ACTIWATCH-SCORE · Mini-Mitter Co., Inc. · Jun 23, 1999

Submission Summary (Full Text)

{0}------------------------------------------------ K132764 JAN 2 1 2014 #### 5.0 510(K) SUMMARY ### Summary information 5.1 - Submitter's name and address 5.1.1 Howard Smith, Engineering Director CamNtech, UK, Ltd. Upper Pendrill Court Ermine Street North -Papworth Everard Cambridge, United Kingdom CB233UY 011-44-1480-831223 Tel: 011-44-1480-831733 Fax: 16" January 2014 Date summary was prepared: 5.1.2 Name of device > Trade Names: Common Name: Classification Name: Product Regulation: Product Code: MotionWatch and PRO-Diary Activity Recording Device Unclassified Unclassified LEL #### Identification of predicate devices 5.1.3. Actiwatch® (Mini-Mitter Co. Inc.), 510(k) Number : K983533 Actiwatch-Score® (Mini-Mitter Co. Inc.), 510(k) Number : K991033 ### 5.2 Device description #### 5.2.1.1 Functions of the device 1 {1}------------------------------------------------ MotionWatch and PRO-Diary are compact, ambulatory, battery-operated activity recorders with physical characteristics similar to a small wristwatch. The MotionWatch and PRO-Diary are intended for the acquisition and analysis of the physical activity of the body during daily living and sleep. The MotionWatch and PRO-Diary use state of the art miniature accelerometer technology to measure movements of the limb or torso and store these data within the devices differ in that the MotionWatch incorporates an ambient light sensor whereby the PRO-Diary incorporates a display and score-pad to allow subjective inputs. The MotionWatch and PRO-Diary require operational software to allow configuration. data download, storage and off-line analysis of activity data by a health, care provider. The software can be run on an IBM-Compatible PC and the device is connected directly by means of a standard Universal Serial Bus connection for configuration and download. ### Basic scientific concepts 5.2.1.2 The MotionWatch and PRO-Diary utilize a motion sensor known as an "accelerometer" to measure the occurrence and degree of motion. The sensor is a solid state device with a digital output directly proportional to physical acceleration in 1, 2 or 3 axes of orientation. The acceleration data are processed into "counts" before being stored in the non-volatile memory of the device. ### <SPACE INTENTIONALLY LEFT BLANK> ### Physical characteristics of Device 5.2.1.3 2 Pertinent physical characteristics of the MotionWatch are shown in Table 5.1. {2}------------------------------------------------ ## TABLE 5.1: PHYSICAL CHARACTERISTICS OF MOTIONWATCH AND | Parameter | MotionWatch | PRO-Diary | Condition/Note | |-----------------------------------|--------------------------------------|----------------------------------------|--------------------------------------------------------------| | Size | 36mm x 28.2mm x 9.4mm | 51.5mm x 34.6mm x 9.4mm | Outer dimensions (excluding strap) | | Weight | 9.1 grams | 16 grams | excluding strap | | Battery Type | CR2032, User replacable | Fixed, rechargeable | | | Battery Life | 6 Months | 3 Weeks | Typical | | Acceleration Range | 0.01g to 8g | 0.01g to 8g | | | Casing material | Polycarbonate/ABS | Polycarbonate/ABS | | | Wrist band | Nylon with stainless steel buckle | Nylon with stainless steel buckle | | | Moisture resistance | IPX71 | IP422 | 1) Water resistant to 1m for 1 hour. 2) Drip resistant | | Sampling Intervals (epochs) | 1 Second to 1 Minute | 1 Second to 1 Minute | User selectable | | Recording time | 6 to 182 days | 6 to 21 days | Depending upon epoch | | Memory | 512KB | 4MB | Non-Volatile | | Indicators | Single LED Status | OLED Display for subjective scoring | | | Storage Temperature | -25°C to 70°C | -25°C to 70°C | 0-93% RH | | Operating Temperature | 5°C to 40°C | 5°C to 40°C | 0-93% RH | ### PRO-DIARY ### Statement of the intended use 5.3 The MotionWatch and PRO-Diary are compact, lightweight, body-worn activity monitoring devices that may be used to document physical movement associated with applications in physiological monitoring. The devices are intended to monitor limb or body movements during daily living and sleep. The MotionWatch and PRO-Diary can be used to assess activity in any instance where quantifiable analysis of physical motion is desired. Additionally, the PRO-Diary has a built-in score pad that allows the wearer to subjectively assign and enter responses to pre-programmed questions. The score pad can ﺩﺭﺍ {3}------------------------------------------------ be used as a substitute or in addition to the traditional written patient diary in conjunction with activity monitoring. ### 5.4 Comparison of the Motion Watch with the predicate device The MotionWatch is substantially equivalent to the predicate [ Actiwatch® FDA 510(k) Number: K983533 ]. The MotionWatch and the Actiwatch® are both physical activity recording systems based upon the concept of an ambulatory, unattended recorder that logs data to the device. Each of these devices is a solid-state recorder with accelerometer sensor, data collection means, and with the ability to store data until it is transferred to a personal computer. The MotionWatch and the Activatch® are of similar mechanical matcrials, construction, size, and human interface characteristics. The MotionWatch and the Activatch® are of similar electronic design and their operational characteristics and indications for use are equivalent. Table 5.2 compares the features of the MotionWatch with those of the Actiwatch® ### <SPACE INTENTIONALLY LEFT BLANK> ## TABLE 5.2. COMPARISON OF MOTIONWATCH TO ACTIWATCH | COMPARISON PARAMETER | MotionWatch (Current Device) | Actiwatch (Predicate Device) | |--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | The MotionWatch and PRO-Diary are compact, lightweight, body-worn activity monitoring devices that may be used to document physical movement associated with applications in physiological monitoring. The devices are intended to monitor limb or body movements during daily living and sleep. The MotionWatch and PRO-Diary can be used to assess activity in any instance where quantifiable analysis of physical motion is desired. Additionally, the PRO-Diary has a built-in score pad that allows the wearer to subjectively assign and enter responses to pre-programmed questions. The score pad can be used as a substitute or in addition to the traditional written patient diary in conjunction with activity monitoring. | The Actiwatch® is an ultra-compact, lightweight, wrist-worn activity and ambient light monitor that can be used to analyze circadian rhythms, automatically collect and store data for sleep parameters, and assess activity in any instance where quantifiable analysis of physical motion is desirable. | | Device general description | Compact, wearable, battery-operated physical activity data recorder | Compact, wearable, battery-operated physical activity data recorder | | Activity channels | 1, 2, or 3 | 1 | | Visual appearance and physical description of Recorder | Plastic molded wristwatch style casing with detachable band. Size 36 x 28.2 x 9.4 (excluding band) | Plastic molded wristwatch style casing with detachable band. Size 37 x 29 x 9 (excluding band) | | Weight | 9.1 grams | 17 grams | | Materials | ABS blend | ABS Blend | | Sampling Intervals (epoch) | 1, 2, 5, 10, 15, 30, 60 seconds | 15, 30, 60, 120, 300, 600 seconds | | Recording time | 182 Days @ 60s epoch | 45 Days @ 60s epoch | | Memory | 512kBytes | 64kBytes | | Raw Sampling rate | 50 Hz | 32 Hz | | A/D conversion | 12 bits | 8 bits | | Frequency | 3 to 11 Hz | 3 to 11 Hz | | Moisture Susceptibility | IPX7 | IPX7 | | Sterility | None required | None required | | Biocompatibility (skin contact type) | Standard nylon wrist band in contact with intact skin surface. | Standard nylon wrist band in contact with intact skin surface. | | Human factors | Worn in wrist like a wristwatch; no user interaction is required. | Worn in wrist like a wristwatch; no user interaction is required. | | Electrical safety (Recorder) | Battery operated | Battery operated | | Power used (Recorder) | 3.0 volt coin cell type CR2032 (1 each, user-replaceable) | 3.0 volt coin cell type CR2025 (1 each, user-replaceable) | | Battery Life (typical) | 6 months | 6 months | | | | | {4}------------------------------------------------ . : 5 {5}------------------------------------------------ ### Comparison of the PRO-Diary with the predicate device ર્સ્ડ The PRO-Diary is substantially equivalent to the predicate [ Actiwatch-Score® FDA 510(k) Number: K991033 ]. The PRO-Diary and the Actiwatch-Score® are both physical activity recording systems based upon the concept of an ambulatory, unattended recorder that logs data to the device. Each of these devices is a solid-state recorder with accelerometer sensor, data collection means, and with the ability to store data until it is transferred to a personal computer. The PRO-Diary and the Actiwatch-Score® both incorporate a score-pad for the prompting and input of subjective patient data. The PRO-Diary and the Activatch-Score® are of similar mechanical materials, construction, size, and human interface characteristics. The PRO-Diary and the Activatch-Score® are of similar electronic design and their operational characteristics and indications for use are equivalent. Table 5.3 compares the features of the PRO-Diary with those of the Actiwatch-Score®. | COMPARISON PARAMETER | PRO-Diary (Current Device) | Actiwatch-Score (Predicate Device) | |-------------------------|-------------------------------|---------------------------------------| |-------------------------|-------------------------------|---------------------------------------| б {6}------------------------------------------------ | Indications For | The MotionWatch and PRO-Diary are | The Actiwatch-Score® is a compact, | |-------------------|---------------------------------------------|----------------------------------------------------------------------------------| | Use | compact, lightweight, body-worn activity | lightweight, wrist-worn activity monitor | | | monitoring devices that may be used to | that can be used to analyze circadian | | | document physical movement associated | rhythms, automatically collect and | | | with applications in physiological | analyze data for sleep parameters, and | | | monitoring. The devices are intended to | assess activity in any instance where | | | monitor limb or body movements during | quantifiable analysis of physical motion | | | daily living and sleep. The MotionWatch | is desirable. In addition, the Actiwatch Score® has a built-in score pad that | | | and PRO-Diary can be used to assess | allows the subject to subjectively assign | | | activity in any instance where quantifiable | and enter a score from 0 to 9. The score | | | analysis of physical motion is desired. | pad can be used as a substitute or in | | | Additionally, the PRO-Diary has a built-in | addition to the traditional patient diary | | | score pad that allows the wearer to | used in conjunction with activity | | | subjectively assign and enter responses to | monitoring. | | | pre-programmed questions. The score pad | | | | can be used as a substitute or in addition | | | | to the traditional written patient diary in | | | | conjunction with activity monitoring. | | | Device general | Compact, wearable, battery-operated | Compact, wearable, battery-operated | | description | physical activity data recorder with | physical activity data recorder with | | | integrated score pad. | integrated score pad. | | Activity channels | 1, 2, or 3 | 1 | | Visual | Plastic molded wristwatch style casing with | Plastic molded wristwatch style casing | | appearance and | detachable band. | with detachable band. | | physical | Size 51.5 x 34.6 x 9.4mm (excluding band) | Size 37 x 35 x 12mm (excluding band) | | description of | | | | Recorder | | | | Weight | 16 grams | 25 grams | | Materials | ABS blend | ABS Blend | | Sampling | 1, 2, 5, 10, 15, 30, 60 seconds | 15, 30, 60, 120, 300, 600 seconds | | Intervals (epoch) | | | | Recording time | 21 Days @ 60s epoch | 45 Days @ 60s epoch | | Memory | 4MBytes | 64kBytes | | Raw Sampling | 50 Hz | 32 Hz | | rate | | | | A/D conversion | 12 bits | 8 bits | | Frequency | 3 to 11 Hz | 3 to 11 Hz | | | | | . . and the comments of the country . . and the comments of the comments of the comments of the comments of {7}------------------------------------------------ | Moisture Susceptibility | IP32 | IP52 | |--------------------------------------------|---------------------------------------------------------------------------------|------------------------------------------------------------------------------| | Sterility | None required | None required | | Biocompatibility (skin contact type) | Standard nylon wrist band in contact with intact skin surface. | Standard nylon wrist band in contact with intact skin surface. | | Human factors | Worn on wrist like a wristwatch; display and score-pad for subjective input. | Worn on wrist like a wristwatch; disp and score-pad for subjective input. | | Electrical safety (Recorder) | Battery operated | Battery operated | | Power used (Recorder) | 3.7 volt rechargeable (1 each, not user- replaceable) | 3.0 volt coin cell type CR2025 (1 each, user-replaceable) | | Battery Life (typical) | 21 days between charging | 6 months between replacement | . . 8 {8}------------------------------------------------ ### · Assessment of non-clinical performance data 5.6 There are no special controls or consensus standards applicable to the measurement of body movement. To verify the performance of the MotionWatch and PRO-Diary a sample of devices were subjected to a suite of bespoke tests to verify each performance parameter. Table 5.4 provides a summary of the MotionWatch non-clinical performance testing. # TABLE 5.4: SUMMARY OF MOTIONWATCH NON-CLINICAL PERFORMANCE TESTING | Requirement summary | Test/verification Method | Pass/fail criteria | Test result | |---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | The device shall measure linear acceleration with an accuracy of +/-5% over the full range | Apply a range of simulated reference acceleration and record the results. | The recorded acceleration over the test range shall meet the requirement. | **PASS** | | The device accuracy shall be <= +/-5% at the calibration point (i.e. 1g). | Collate random sample of calibration records and examine inter-device variation. | The variation in calibration values shall meet or exceed the requirement. | **PASS** | | The device shall have a frequency response of 3 to 11 Hz | Apply a fixed acceleration over a range of frequencies and record the results | The frequency response shall meet the requirement to within +/- 10% | **PASS** | | The device shall output zero counts when no physical stimulus is applied | Set-up a sample device and record for a period with no physical stimulus. | The device shall record zero for the period of no physical stimulus. | **PASS**. | | The light sensor shall have an accuracy of +/- 7.5% over the stated range. | Record a range of light from darkness to sunlight with a sample device simultaneously with a calibrated light meter. Compare the results | The device shall meet the requirement, however it is acceptable that the accuracy worsens as light level increases. The accuracy over particular ranges shall be specified in the IFU. | **PASS**. | | The device shall output zero lux when the sensor is in total darkness | Record data with the light sensor covered with fully opaque tape. | The device shall record zero lux for the test period. | **PASS** | | The device shall recover from unexpected reset events and/or total loss of power with no effect on the stored data. | A sample device shall be subjected to multiple power on reset events and the stored data shall be subsequently downloaded and examined | No loss of function/data shall occur following the multiple reset events. | **PASS** | {9}------------------------------------------------ Table 5.5 provides a summary of the PRO-Diary non-clinical performance testing. # TABLE 5.5: SUMMARY OF PRO-DIARY NON-CLINICAL PERFORMANCE TESTING | Requirement summary | Test/verification Method | Pass/fail criteria | Test result | |----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-------------| | The device shall measure linear acceleration with an accuracy of +/-5% over the full range | Apply a range of simulated reference acceleration and record the results. | The recorded acceleration over the test range shall meet the requirement. | **PASS** | | The device accuracy shall be <= +/-5% at the calibration point (i.e. 1g). | Collate random sample of calibration records and examine inter-device variation. | The variation in calibration values shall meet or exceed the requirement. | **PASS** | | The device shall have a frequency response of 3 to 11 Hz | Apply a fixed acceleration over a range of frequencies and record the results | The frequency response shall meet the requirement to within +/- 10% | **PASS** | | The device shall output zero counts when no physical stimulus is applied | Set-up a sample device and record for a period with no physical stimulus. | The device shall record zero for the period of no physical stimulus. | **PASS** | | The display shall be legible in low-light conditions (<100 lux) with normal corrected vision. | A sample device is observed under the stated light conditions | The display shall be legible in accordance with the requirements | **PASS** | | The display shall be legible in bright-light conditions (<20000 lux) with normal corrected vision. | A sample device is observed under the stated light conditions | The display shall be legible in accordance with the requirements | **PASS** | | The responses to questions shall be accurately recorded and displayed in the results viewer. | A sample device is used to record entries pre-defined in a written log. The downloaded and displayed data are compared to the written log. | There shall be no differences between the electronically reported data and the written log | **PASS** | In addition to performance testing, the devices have been evaluated and tested for safety and electromagnetic interference according to the following internationally recognized standards: IEC60601-1: 2005 Medical Electrical Equipment – General Requirements for Basic Safety and Essential Performance. {10}------------------------------------------------ IEC60601-1-11:2010 Medical Electrical Equipment – General Requirements for Basic Safety and Essential Performance. Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. IEC60601-1-2: 2007, Medical Electrical Equipment - PART 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests. The testing according to these standards has raised no issues as to the safety and effectiveness of the present devices or the present devices compared to the predicate devices. ### 5.7 Conclusion | | The results of the performance testing and safety and environmental testing show that the MotionWatch and PRO-Diary are as safe, as effective, and perform as well as the predicate device. ## <SPACE INTENTIONALLY LEFT BLANK> {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 21, 2014 CamNtech Ltd. c/o Mr. Howard Smith Engineering Director Upper Pendrill Court Ermine Street North Papworth Everard. Cambridge, United Kingdom CB233UY Re: K132764 Trade/Device Name: MotionWatch and PRO-Diary Regulation Number: Unclassified Common Name: Sleep Assessment Device (Activity Recorder) Regulatory Class: Class II Product Code: LEL Dated: December 16, 2013 Received: December 17, 2013 Dear Mr. Smith: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {12}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Carlos L. Pena -S Carlos L. Peña, Ph.D., M.S. Director Division of Neurological " and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {13}------------------------------------------------ ### Indications for Use 510(k) Number: K132764 Device Name: MotionWatch and PRO-Diary ### Indications for Use: The MotionWatch and PRO-Diary are compact, lightweight, body-worn activity monitoring devices that may be used to document physical movement associated with applications in physiological monitoring. The devices are intended to monitor limb or body movements during daily living and sleep. The MotionWatch and PRO-Diary can be used to assess activity in any instance where quantifiable analysis of physical motion is desired. Additionally, the PRO-Diary has a built-in score pad that allows the wearer to subjectively assign and enter responses to pre-programmed questions. The score pad can be used as a substitute or in addition to the traditional written patient diary in conjunction with activity monitoring. AND/OR Prescription Use X ..... (part 21 CFR 801 Subpart D) Over-The-Counter Use_ (21 CFR 801 Subpart C) ## (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center of Devices and Radiological Health (CDRH) Carlos L. Pena -S page 1 of ____________________________________________________________________________________________________________________________________________________________________