Apex Medical Digital TENS TS1211, TS1212
510(k) K021755
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK021755 | Date12 Jun 2002 | 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- Withdrawn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, 1 Oct 2026
The Apex Medical Digital TENS TS1211 and TS1212 are transcutaneous electrical nerve stimulators (TENS) designed for pain relief. These devices deliver controlled electrical pulses through adhesive electrodes placed on the skin to stimulate peripheral nerves, providing symptomatic relief for chronic, post-traumatic, or post-surgical pain. Classified under the product code GZJ, they fall under the regulatory category of nerve stimulators intended for neurological applications. Their function relies on modulating nerve signals to alleviate discomfort without invasive procedures.
These devices are supplied as reusable medical instruments and are regulated under FDA 510(k) clearance (K021755) with a decision of Substantially Equivalent (SESE). They are intended for use in clinical or home settings by trained personnel or patients under medical supervision. No specific sterility requirements are noted, but proper cleaning and maintenance are implied for reusable use. The devices are not labeled for MRI compatibility or single-use, and their storage conditions are not detailed in the regulatory data.
Other devices from Apex Medical Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Apex Medical Digital TENS TS1211/TS1212 used for?
This device is designed to provide symptomatic relief for chronic, post-traumatic, or post-surgical pain. It works by delivering controlled electrical pulses through adhesive electrodes placed on the skin, stimulating peripheral nerves to modulate discomfort without invasive procedures. It is intended for use in clinical or home settings by trained personnel or patients under medical supervision.
Are the Apex Medical TENS TS1211 and TS1212 single-use or reusable?
These devices are supplied as reusable medical instruments. Since they are not labeled for single-use, proper cleaning and maintenance are required to ensure safe and effective repeated use. No specific sterility requirements are noted in the regulatory data, but standard hygiene practices should be followed.
What regulatory approval does the Apex Medical Digital TENS TS1211/TS1212 have?
The device holds FDA 510(k) clearance under the reference number K021755, classified as Substantially Equivalent (SESE). It falls under the product code GZJ and is regulated as a nerve stimulator for neurological applications, reviewed by the Neurology Advisory Committee.
Can the Apex Medical TENS TS1211/TS1212 be used in an MRI environment?
The regulatory data does not specify MRI compatibility for these devices. Users should consult the manufacturer’s instructions and local guidelines before using them in an MRI setting to avoid potential risks such as interference or injury.
How should the Apex Medical Digital TENS TS1211/TS1212 be stored?
The storage conditions for these devices are not detailed in the regulatory data. However, as reusable instruments, they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Follow manufacturer guidelines for optimal longevity and functionality.