Etg 255 Combo Stimualtor, Ten 260 Stimualtor
510(k) K110390
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK110390 | Date29 Jul 2011 | 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- Withdrawn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
- 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, 19 Sep 2026
The ETG 255 Combo Stimulator and TEN 260 Stimulator are transcutaneous nerve stimulators designed for pain relief. These devices deliver electrical impulses to nerve pathways to modulate pain signals, adhering to the classification of ‘Stimulator, Nerve, Transcutaneous, For Pain Relief’ under FDA regulation 882.5890. They are intended for use in neurology applications, targeting chronic pain management through non-invasive stimulation.
These devices are supplied as reusable medical equipment and are regulated under FDA 510(k) clearance (K110390) with a classification of Class II. They are intended for clinical use in controlled settings, such as hospitals or pain management clinics, and require proper training for operation. No specific sterility or single-use designation is noted in the regulatory submission.
Questions
AI-generated answers, 19 Sep 2026
Are the ETG 255 Combo Stimulator and TEN 260 Stimulator designed for single-use or can they be reused in a clinical setting?
The ETG 255 Combo Stimulator and TEN 260 Stimulator are explicitly described as reusable medical equipment in the regulatory submission. Since they are classified as reusable devices, they are intended for use across multiple patients in controlled environments like hospitals or pain management clinics, provided proper cleaning, maintenance, and sterilization protocols are followed.
What types of pain conditions are these stimulators intended to address, and in what clinical setting are they typically used?
These devices are intended for chronic pain management within the field of neurology, specifically targeting pain relief through transcutaneous nerve stimulation. They are designed for use in clinical settings such as hospitals or pain management clinics, where trained personnel can administer the therapy under controlled conditions.
How are these stimulators regulated in the U.S., and what does the FDA’s classification mean for their use?
The ETG 255 Combo Stimulator and TEN 260 Stimulator are regulated under FDA 510(k) clearance (K110390) and classified as Class II devices. This classification indicates they are subject to special controls to ensure safety and effectiveness, including performance standards and post-market surveillance, while still allowing for broader distribution than Class III devices.
What is the primary difference between the ETG 255 Combo Stimulator and the TEN 260 Stimulator in terms of their intended use?
Both devices fall under the same transcutaneous nerve stimulator category for pain relief, but the ETG 255 Combo Stimulator and TEN 260 Stimulator are listed as distinct models under the same regulatory submission. While the exact functional differences aren’t detailed in the submission, the naming suggests they may offer complementary features or configurations for clinical flexibility, such as varying stimulation patterns or electrode options, without altering their core indication for chronic pain management.