FDA 510(k) · Camntech
K132764: MOTION WATCH AND PRO-DIARY (Camntech, Ltd.)
Camntech, Ltd. received FDA 510(k) K132764 for MOTION WATCH AND PRO-DIARY, with a decision date of Jan 21, 2014 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K132764 |
|---|---|
| Pathway | 510(k) |
| Applicant | Camntech, Ltd. |
| Device name | MOTION WATCH AND PRO-DIARY |
| Product code | LEL: Device, Sleep Assessment |
| Regulation (21 CFR) | 882.5050 |
| Device class | Class 2 |
| Date received | Sep 4, 2013 |
| Decision date | Jan 21, 2014 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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. Prescription Use X AND/OR Over-The-Counter Use______ (part 21 CFR 801 Subpart D) (21 CFR 801 SubpartC) (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 pagelIof I
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
Later records that cite K132764
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code LEL is "Device, Sleep Assessment", class 2, 21 CFR 882.5050.
Our labels for filtering: claim Sleep, sensor Wrist PPG. These are heuristics, not FDA fields.