(250 days)
Not Found
No
The description details a standard TENS device with preset programs and adjustable intensity, with no mention of AI or ML capabilities.
Yes
The device is intended for "symptomatic relief and management of chronic intractable pain and relief of pain associated with arthritis," as well as "adjunctive treatment in the management of post-surgical and post-traumatic pain," which are therapeutic applications.
No
The device is a Transcutaneous Electrical Nerve Stimulator (TENS) used for pain relief, which is a therapeutic function, not a diagnostic one. It does not identify or characterize diseases or conditions.
No
The device description explicitly details hardware components such as batteries, output channels, intensity buttons, an on/off button, a plastic case, an LCD display, a keypad, and a battery storage compartment. It also describes electrical and mechanical testing, which is characteristic of hardware devices.
Based on the provided information, the Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Staodyn® Max Preset is a Transcutaneous Electrical Nerve Stimulator (TENS) that transmits electrical pulses through the skin to the underlying peripheral nerves. Its intended use is for pain relief and management. This is a direct interaction with the body, not a test performed on a sample outside the body.
Therefore, the Staodyn® Max Preset is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device is used for the symptomatic relief and management of chronic intractable pain and relief of pain associated with arthritis. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
Product codes (comma separated list FDA assigned to the subject device)
GZJ, NYN
Device Description
The Staodyn® Max Preset is a Transcutaneous Electrical Nerve Stimulator (TENS) that transmits small electrical pulses through the skin to the underlying peripheral nerves. It is battery operated using 3-AAA batteries and includes two controllable output channels. It generates and delivers electrical impulses whose duration, rate and modulation can be altered by selection of 24 preset programs. The amplitude of the impulses can be increased or decreased with the use of two intensity toggle buttons, one for each output channel. The device has an on/off button that enables the device to be turned on off. In addition, the on/off button can be used to pause a treatment program during use. The stimulator is housed in a molded portable plastic case with a viewable LCD display, accessible keypad, and accessible battery storage compartment.
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
Not Found
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 Testing: Verification of the Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device includes electrical and mechanical tests to show that the device meets its product specifications over a range of operating and storage conditions. Validation testing for the Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device includes testing to show the device meets user needs according to marketing requirements.
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.
American Imex Premier Plus -K032003
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
KO 615/6
510(k) Summary
Compex Technologies Inc. Staodyn® Max preset TENS Device
510(k) Number 061516
Date of Summary Preparation:
April 4, 2006
FEB 6 2007
Submitter/Contact Person:
Carl Beaurline Global Vice President Regulatory Affairs COMPEX Technologies, Inc. 1811 Old Highway 8 New Brighton, MN 55112
Phone: (651) 389-0771 Fax: (651) 638-0477
Device Name and Classification:
Trade Name: Staodyn® Max Preset Common Name: Transcutaneous Electrical Nerve Stimulator Classification Name: TENS device Product Code: GZJ , NYN Classification: Class II - 21CFR 882.5890
Manufacturing Location:
OEM: Tyece, Ltd. Establishment Registration Number: N/A Room 502-3, Po Hing Centre 18 Wang Chiu Road, Kowloon Bay Hong Kong Telephone: 852-2349-7456 Fax: 852-2349-9166
Axelgaard MFG. Co. LTD. Establishment Registration Number: 2025066 329 West Aviation Rd. Fallbrook, CA 92028 Tel: 720-723-7554 Fax:
COMPEX Technologies Establishment Registration Number: 2126518 1811 Old Highway 8
1
New Brighton, MN 55112 Tel: 651-389-0771 Fax: 651-638-0477
Predicate Devices:
American Imex Premier Plus -K032003
Intended Use:
The Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device is used for the symptomatic relief and management of chronic intractable pain and relief of pain associated with arthritis. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
Device Description:
The Staodyn® Max Preset is a Transcutaneous Electrical Nerve Stimulator (TENS) that transmits small electrical pulses through the skin to the underlying peripheral nerves. It is battery operated using 3-AAA batteries and includes two controllable output channels. It generates and delivers electrical impulses whose duration, rate and modulation can be altered by selection of 24 preset programs. The amplitude of the impulses can be increased or decreased with the use of two intensity toggle buttons, one for each output channel. The device has an on/off button that enables the device to be turned on off. In addition, the on/off button can be used to pause a treatment program during use. The stimulator is housed in a molded portable plastic case with a viewable LCD display, accessible keypad, and accessible battery storage compartment.
Comparison to predicate:
The Staodyn® Max Preset TENS is substantially equivalent to the IMEX Premier Plus TENS device. The function, performance, and intended use of the Staodyn® Max Preset device is very similar to the Premier Plus. Both systems are designed to relieve pain. The outputs are virtually identical. Each can produce a symmetric biphasic pulse with peak voltage up to 50 Volts on 500 ohms load. Both devices allow the user to select preset programs and set the intensity from 1 to 20 by using a keypad and LCD display of the devices. Both devices have the ability to detect when the lead were open and have Auto shut off feature.
Non-clinical Testing:
Verification of the Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device includes electrical and mechanical tests to show that the device meets its product specifications over a range of operating and storage conditions. Validation testing for the Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device includes testing to show the device meets user needs according to marketing requirements.
Clinical Testing:
2
COMPEX Technologies. Inc.
The Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device does not require clinical testing in order to determine substantial equivalence to the predicate devices.
Conclusion:
The non-clinical testing demonstrates that the Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device is safe, effective, and performs as well as the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
. . .
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Carl Beaurline Vice President, Regulatory Affairs Compex Technologies, Inc. 1811 Old Highway 8 New Brighton, Minnesota 55112
FEB 6 2007
Re: K061516
Trade/Device Name: Staodyn® Max Preset, Model 4470 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Codes: GZJ, NYN Dated: December 7, 2006 Received: December 8, 2006
Dear Mr. Beaurline:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 mr 1), it a can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if
4
Page 2 - Mr. Carl Beaurline
applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mar J. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
1 Indication for Use Statement
Indications for Use
510(k) Number (if known): __ K061516
Device Name: The Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device
Indications for Use:
... ... ......................................................................................................................................................................
The Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device is used for the symptomatic relief and management of chronic intractable pain and relief of pain associated with arthritis. It is also used as an adjunctive treatment in the manager of purf post-surgical and post-traumatic pain.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X | |
|---|---|---|
| AND/OR | Over-the-Counter Use | |
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONT(Division Sign-Off IF NEEDED))
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
510(k) Number: 11061511
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