(296 days)
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No
The device description details standard electrical stimulation parameters and modes, with no mention of adaptive algorithms, learning capabilities, or data processing that would indicate AI/ML. The comparison to a predicate TENS device further suggests a conventional technology.
Yes
The device is indicated for the symptomatic relief and management of chronic pain, and as an adjunctive treatment for acute pain, which are therapeutic applications.
No
The device is a Transcutaneous Electrical Nerve Stimulator (TENS) used for pain relief, not for diagnosing medical conditions. Its intended use is detailed as "symptomatic relief and management of chronic (long-term) intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain." There is no mention of it performing any diagnostic function.
No
The device description clearly outlines physical hardware components such as batteries, output channels, size, and weight, indicating it is a physical device, not software-only.
Based on the provided information, the SEIN SE-30 TENS device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the symptomatic relief and management of pain. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS). TENS devices deliver electrical impulses to the skin to alleviate pain. This is a physical therapy modality, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
In summary, the SEIN SE-30 TENS device is a therapeutic device used for pain management, not a diagnostic device used for analyzing biological samples.
N/A
Intended Use / Indications for Use
the SEIN SE-30 TENS device is indicated for the symptomatic relief and management of chronic (long-term) intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
Product codes
GZJ
Device Description
The SEIN SE-30 TENS device is a Transcutaneous Electrical Nerve Stimulator. It has one output channel, produces an asymmetric bi-phasic & phasic rectangular shape with zero net direct current pulse, with pulse width programmable from 105-450 us and pulse rate programmable from 1-200 pulse/sec. It is powered by two alkaline AAA batteries (1.5 volt). It includes multiple modes: Mode 1 [Modulation] (Pulse Rate: 1-100 pps, Pulse Width: 220-450 usec), Mode 2 [Burst] (Pulse Rate: 16 pulse/burst. 4b/sec, 16 pulse/burst. 7b/sec, 63-125 pps; Pulse Width: 105-450 usec), Mode 3 [Modulation] (Pulse Rate: 1-5 pps, Pulse Width: 220 usec), and Mode 4 [Burst] (Pulse Rate: 220 pulse/burst, 1b/sec, 90 pulse/burst. 1b/sec; Pulse Width: 220-450 usec). The device dimensions are 70(W) x 79(H) x 17(D) mm and it weighs 80 grams. It uses adhesive type gel pads and automatically changes polarity. Treatment duration is 15 minutes with no daily limit.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The SE-30 TENS device was tested according to the standards of ANSI/AAMI NS4-1985 and was found to meet the requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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
出事
K99 139 7
11/3
ELECTRONICS CO. , LTD. SEIN
133-3 PYUNGCHON-DONG, DONGAN-GU, ANYANG-SHI, KYUNGKI-DO, KOREA TEL: ANYANG (0343) 421-0389, FAX:(0343)421-5639
510(k) SUMMARY
"This 510(k) summary of Safety and Effectiveness information is being summitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. "
The assigned 510(k) number is _ __________ a market met service and the sense the sense many of
Applicant SEIN Electronics Co.,Ltd. 133-3 Pyungchon-Dong, Dongan-Gu, Anyang-Shi, Kyungki-Do, Korea Tel:Anyang(0343)421-0389 Fax:(0343)421-5639
Mr. S. H. Hwang, President Contact Forecare, Inc. 1540 Barclay Boulevard Buffalo Grove, IL 60089 Tel: (847)541-8894 Fax: (847)541-8979
Date March 16, 1999
Name of Device
Proprietary Name : SE-30 TENS Common or Usual Name : Transcutaneous Electrical Nerve Stimulator Classification Name : Stimulator, Nerve, Transcutaneous (Pain Relief)
The SEIN SE-30 TENS device is equivalent to the Graham-Field, Inc. Micro TENS Plus transcutaneous electrical nerve stimulator.
Each product is used for the symptomatic relief of and management of long term intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
1
A comparison of general specifications between the two devices is as follows:
| SEIN | GRAHAM-FIELD | |
|---|---|---|
| ITEM | SE-30 TENS | Micro TENS Plus |
| Output Channels | One output channel | Two with individual controls |
| Pulse Shape | Asymmetric bi-phasic & | |
| phasic rectangular shape with | ||
| zero net direct current | Asymmetric bi-phasic & | |
| phasic rectangular shape with | ||
| zero net direct current | ||
| Pulse Width | 105-450 us programmed insert | |
| protected circuit | 50-200 us variable | |
| Pulse Rate | 1-200 pulse/sec programmed | 1-200 pulse/sec variable |
| Power Source | two alkaline AAA batteries | |
| 1.5 volt | 9 volt alkaline or NiCd bat. | |
| (rechargeable option) | ||
| Maximum Voltage | ||
| Load | 26 V | 17 V |
| 200 ohm | 40 V | 32 V |
| 500 ohm | 52 V | 45 V |
| 1 Kohm | 90 V | 90 V |
| open | ||
| Maximum Output | ||
| charge/pulse | ||
| (500 ohm load for safety) | 58.5 uc/pulse | 14.3 uc/pulse |
| Maximum Output | ||
| average current | ||
| (500 ohm load for safety) | 3.375 mA | 2.3 mA |
| Size | 70(W) x 79(H) x 17(D) mm | 90(W) x 59(H) x 25(D) mm |
| Weight | 80 grams | 142 grams |
| Recharge Battery Option | N | Y |
| Battery Check | N | Y |
| Water Use Option | N | Y |
| Discriminate Polality | Automatically Change | Required |
| Gel Pad | Adhesive Type | Adhesive Type |
| Treatment | 15 min. (no daily limit) | |
| Mode 1: [Modulation] |
- Pulse Rate : 1-100 pps
- Pulse Width: 220-450 usec | 15, 30min. (no daily limit)
Constant Mode - Pulse Rate : 1-200 pps
- Pulse Width: 50-200 usec |
| MODES AVAILABLE | Mode 2... [Burst] - Pulse Rate:
16 pulse/burst. 4b/sec
16 pulse/burst. 7b/sec
63-125 pps - Pulse Width : 105-450 usec | Burst Mode
- Pulse Rate:
10 pulse/burst. 2b/sec - Pulse Width: 50-200 usec |
| | Mode 3... [Modulation] - Pulse Rate : 1-5 pps
- Pulse Width : 220 usec | Modulation Mode
- Pulse Rate : 1-200 pps
- Pulse Width: 50-200 usec |
| | Mode 4... [Burst] - Pulse Rate:
220 pulse/burst, 1b/sec
90 pulse/burst. 1b/sec - Pulse Width: 220-450 usec | |
2
The SE-30 TENS device also was tested according to the standards of ANSI/AAMI NS4-1985 and was found to meet the requirements.
Mar. 16. 1999
Date
Tung
Tae Young Choi, President
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized symbol consisting of three abstract human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, bold line style.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2000
Mr. S. H. Hwang President SEIN Electronics Company, Ltd. C/O Forecare, Inc. 1540 Barclay Boulevard Buffalo Grove, Illinois 60089
Re: K991397
Trade Name: Transcutaneous Electrical Nerve Stimulator SE-30 TENS Regulatory Class: II Product Code: GZJ Dated: November 8, 1999 Received: November 18, 1999
Dear Mr. Hwang:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed
4
Page 2 – Mr. S. H. Hwang
predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
Mark N. Melkerson
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
Device Name: Transcutaneous Electrical Nerve Stimulator - SE-30 TENS
Indications For Use: the SEIN SE-30 TENS device is indicated for the symptomatic relief and management of chronic (long-term) intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use
Prescription Use × (Per 21 CFR801.109)
OR
(Optional Format 1-2-96)