Transcutaneous Electrical Nerve Stimulation (GZJ)
510(k) K896787
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK896787 | Date30 Jul 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Transcutaneous Electrical Nerve Stimulation
- 510(k) Number
- FDA Product Code
- GZJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5890
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
Transcutaneous Electrical Nerve Stimulation (TENS) is a Class II medical device designed to deliver low-voltage electrical currents transcutaneously to modulate pain perception. It operates by stimulating peripheral nerves to block or alter pain signals, providing non-invasive therapeutic relief for acute or chronic pain conditions. The device is intended for external application and does not involve implantation or internal modification of the body. Its primary function is pain management through controlled electrical stimulation, adhering to established neuromodulation principles.
The device is supplied as a reusable medical instrument, intended for use in clinical, home, or outpatient settings under professional supervision or patient self-administration. It requires no sterility as it is not invasive, though electrodes and cables must be maintained in clean, dry conditions to ensure safe operation. Compliance with FDA 510(k) clearance (K896787) confirms its substantial equivalence to a predicate device, with regulatory oversight under the Neurology Advisory Committee. No MRI safety classification or single-use designation is specified in the data.
Other devices from Saratoga Intl., Inc.
Questions
AI-generated answers, 20 Sep 2026
Is this TENS device meant for single-use or can it be reused in a clinical setting?
This TENS device is designed as a reusable medical instrument, suitable for use in clinical, home, or outpatient settings. Since it is non-invasive and does not require sterility, it can be reused provided electrodes and cables are kept clean and dry to ensure safe operation. However, proper maintenance and hygiene practices must be followed to prevent contamination or malfunction.
How is the TENS device regulated, and what committee oversees its approval process?
The device is regulated under the FDA’s 510(k) clearance pathway, specifically classified as a Class II medical device. Its substantial equivalence to a predicate device was confirmed by the Neurology Advisory Committee (NE), ensuring compliance with neuromodulation principles for pain management. The clearance number is K896787, and the device falls under product code GZJ.
Can this TENS device be used in a home setting, and what precautions should be taken?
Yes, this TENS device is intended for use in home settings under professional supervision or patient self-administration. Since it is non-invasive, sterility is not required, but electrodes and cables must remain clean and dry to avoid skin irritation or electrical hazards. Users should follow manufacturer guidelines for proper application and maintenance to ensure safe and effective pain management.
What types of pain conditions is this TENS device designed to address, and how does it work?
This TENS device is designed to modulate pain perception by delivering low-voltage electrical currents transcutaneously, stimulating peripheral nerves to block or alter pain signals. It is intended for non-invasive therapeutic relief of acute or chronic pain conditions, operating on established neuromodulation principles without implantation or internal modification of the body.
Does this TENS device have any special storage requirements, and is it safe for use near MRI machines?
The device does not specify special storage requirements beyond maintaining clean, dry conditions for electrodes and cables. However, since no MRI safety classification is mentioned in the data, it is not recommended for use near MRI machines unless explicitly verified by the manufacturer, as electromagnetic interference could pose risks to both the device and the patient.