(32 days)
Not Found
No
The description focuses on standard TENS technology and does not mention AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is a Transcutaneous Electrical Nerve Stimulator (TENS) designed to control and relieve pain, which is a therapeutic function.
No
Explanation: The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS) used for symptomatic relief and management of pain, which is a therapeutic application, not a diagnostic one. It delivers electrical current to control pain, not to identify or diagnose a condition.
No
The device description explicitly states the system is comprised of a stimulator and battery, indicating hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for pain relief and management through electrical stimulation applied to the skin. This is a therapeutic application, not a diagnostic one.
- Device Description: The description confirms it's a Transcutaneous Electrical Nerve Stimulator (TENS) that delivers electrical current through the skin. This is a physical intervention, not a test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
TENS applications:
- Symptomatic relief and management of chronic, intractable pain .
- Adjunctive treatment for post-surgical and post-trauma acute pain .
Product codes (comma separated list FDA assigned to the subject device)
GZJ
Device Description
The Fenzian Treatment System is an electrical device designed for use as a Transcutaneous Electrical Nerve Stimulator (TENS) which operates by delivering an electrical current through the skin to the cutaneous (surface) and afferent (deep) nerves to control pain. The complete system is comprised of the stimulator and battery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Data:
-
- Risk Analysis results demonstrate acceptable and mitigated potential hazards.
-
- The device meets the requirements for EN 60601-1-2 EMC, Radiated Emissions, Electrostatic Discharge, Radiated Immunity and device safety.
-
- The device meets European requirements for application of the CE Mark.
Conclusion:
The device is designed and labeled and verified for performance and safety. The performance is equivalent to a legally marketed predicate device. Risk Analysis does not demonstrate any design or performance potential hazards that are not adequately mitigated.
- The device meets European requirements for application of the CE Mark.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
K041575
510k Summary
pg 1 of 7
JUL 1 6 2004
510(k) Summary Fenzian Treatment System
Eumedic Limited 3 Charnham Lane Hungerford, Berkshire RG170EY United Kingdom 44(0)1488684008 Dominic Weiss, Director
Prepared 6-11-04 by: L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301 303-530-3279 303-530-4774 (fax)
1
510 k Summary
p 2 of 7
| Device: | Fenzian Treatment System |
|---|---|
| Common Name: | Transcutaneous Electrical Nerve Stimulator |
| Classification | 882.5890 TENS |
| SE Predicate: | Empi Focus 795 |
| K951951 | |
| 882.5890 |
Device Description: The Fenzian Treatment System is an electrical device designed for use as a Transcutaneous Electrical Nerve Stimulator (TENS) which operates by delivering an electrical current through the skin to the cutaneous (surface) and afferent (deep) nerves to control pain. The complete system is comprised of the stimulator and battery.
2
Indications for Use
510(k) Number (if known):
Device Name: Fenzian Treatment System
Indications For Use:
TENS applications:
- Symptomatic relief and management of chronic, intractable pain .
- Adjunctive treatment for post-surgical and post-trauma acute pain .
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEDDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
3
COMPARISON CHART
:
:
| Feature/Characteristic | Fenzian Treatment System | EMPI - Focus 795, Published Specs |
|---|---|---|
| 510(k) | Unassigned. Application in process. | K951951 |
| Manufacturer | Eumedic Ltd. | |
| 3 Charnham Lane | ||
| Hungerford Berkshire RG170EY | ||
| United Kingdom | Empi, Inc. | |
| 49 Plain Street | ||
| North Attleboro, MA 02760 | ||
| U.S.A. | ||
| Device Classification | Transcutaneous Nerve Stimulator | |
| (TENS) 882.5890 | Transcutaneous Nerve Stimulator | |
| (TENS) 882.5890 | ||
| Product Code | 84 GZJ TENS | 84 GZJ TENS |
| Indications | As a TENS device: | |
| a) Symptomatic relief and management of chronic, intractable pain | ||
| b) Adjunctive treatment for post-surgical and post-trauma acute pain | As a TENS device: | |
| a) Symptomatic relief and management of chronic, intractable pain | ||
| b) Adjunctive treatment for post-surgical and post-trauma acute pain | ||
| Output channels | 1, alternating | 2, simultaneous |
| Regulated voltage | Yes | Yes |
| Indicator display |
- On/Off display | Yes | Yes |
| - Low Battery | Yes | Yes |
| Weight | 0.4 kg excl. batteries | 145 gm with battery |
| Dimensions | 7 x 2 x 2 inches | 3.7 x 2.5 x 0.84 inches |
| Electrodes | Stainless steel | Snapease Brand |
| Waveform | Biphasic | Symmetrical biphasic |
| Maximum Output Voltages | 88 V @ 500 ohms
306 V @ 2 k ohms
650 V @ 10 k ohms | $\pm$ 100V @ 1 k ohm |
| Maximum Output Current | 46 milliamps @ 500 ohms
16.8 milliamps @ 2 k ohms
8.0 milliamps @ 10 k ohms | 0-60 mA (normal)
0-100 mA (high) |
| Pulse width | 498 $\mu$ S | 300 $\mu$ S of peak amplitude |
| Frequency | 15-350 Hz | 25, 30, 35, 45, 50, 80 pps |
| Net Charge | 1.16 $\mu$ C@ 500 ohms | 30 $\mu$ C |
| Max. Phase Charge | 10.6 $\mu$ C @ 500 ohms | 40 $\mu$ C @ 500 ohm |
| Feature/Characteristic | Fenzian Treatment System | EMPI - Focus 795, Published
Specs |
| Max. Current Density
(mA/cm²) | 27.7 mA/cm² @ 500 ohms | 3.11 mA/cm² @ 500 ohms |
| Avg. Power Density
(W/cm²) | 0.177 W/cm² @ 500 ohms | 0.187 W/cm² @ 500 ohms |
| Burst Mode | | Unknown |
| - Pulses per burst | 1-8 | |
| - Bursts per second | 15-2800 | |
| - Burst duration | 1-5 seconds | |
| Time On | 1-5 seconds | 2.5 – 50 seconds |
| Off Time | 1 second | 0-50 seconds |
| Power Supply Voltage | 9V | 9V |
| Max. Delivered Current |