FDA 510(k) · TMS Telemedizinische Systeme
K050670: SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS (Tms Telemedizinische Systeme GmbH)
Tms Telemedizinische Systeme GmbH received FDA 510(k) K050670 for SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS, with a decision date of Mar 30, 2005 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K050670 |
|---|---|
| Pathway | 510(k) |
| Applicant | Tms Telemedizinische Systeme GmbH |
| Device name | SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS |
| Product code | DXH: Transmitters And Receivers, Electrocardiograph, Telephone |
| Regulation (21 CFR) | 870.2920 |
| Device class | Class 2 |
| Date received | Mar 15, 2005 |
| Decision date | Mar 30, 2005 |
| 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
'Symptomatic disturbances of cardiac rhythm such as palpitations, fatigue, heart racing, fluttering, chest discomfort or pain. Project No.: 3015 File: 510k-summary.sxw 'Copyright TiS Telemedizinische Systerne GmbH Copy prohibited without prior written permission of TMS Telemedizinische Systeme GmbH page 5- 1 510(K) Submission ,,sensor mobile" SM100/1001R Document: Sec. 5,
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.
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 DXH is "Transmitters And Receivers, Electrocardiograph, Telephone", class 2, 21 CFR 870.2920.
Our labels for filtering: claim ECG, sensor ECG electrodes. These are heuristics, not FDA fields.