FDA 510(k) · Taiwan Scientific
K123130: ANSWATCH WRIST MONITOR MODEL TS-0411 (Taiwan Scientific Corporation)
Taiwan Scientific Corporation received FDA 510(k) K123130 for ANSWATCH WRIST MONITOR MODEL TS-0411, with a decision date of Sep 17, 2013 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K123130 |
|---|---|
| Pathway | 510(k) |
| Applicant | Taiwan Scientific Corporation |
| Device name | ANSWATCH WRIST MONITOR MODEL TS-0411 |
| Product code | DXN: System, Measurement, Blood-Pressure, Non-Invasive |
| Regulation (21 CFR) | 870.1130 |
| Device class | Class 2 |
| Date received | Oct 4, 2012 |
| Decision date | Sep 17, 2013 |
| 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
Statement Indication for Use 510(k) Number (if known): K123130 Device Name: I-RVWatch Wrist Monitor Indications for Use: Non-invasive measurement of systolic pressure (SYS), diastolic pressure (DIA), heart rate (HIR), heart rate variability (HRV), and irregular heartbeats (Ir-rHB) for professionals at office or patients at home under the supervision of a trained professional. The device is not intended for ambulatory use. The device is designed for wearing on the left wrist only. The device provides a I-WV parameter which is only mathematical, analysis and is not intended to produce any interpretation of those measurements or any kind of diagnosis. Prescription Use AN Over-The-Counter Use _ (Part 21 CFR 801 Subpart D) (21 CER 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) rC en Faris Digitally signed by - Date,2013 09 17 Page I of 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 K123130
- K201914 HRVWatch-Mini Wrist Monitor (Taiwan Scientific, Jun 7, 2021, DXN)
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 DXN is "System, Measurement, Blood-Pressure, Non-Invasive", class 2, 21 CFR 870.1130.
Our labels for filtering: claim Blood pressure, sensor Cuff. These are heuristics, not FDA fields.