Stimulator, Model 7727
510(k) K782075
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK782075 | Date14 Dec 1978 | 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- Withdrawn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 Stimulator, Model 7727 is a transcutaneous nerve stimulator designed for pain relief. Classified under product code GZJ, it falls under the category of nerve stimulators intended to modulate pain signals via electrical stimulation applied to the skin. This device delivers controlled electrical impulses to targeted nerve pathways, providing non-invasive therapeutic intervention for chronic or acute pain management. Its primary function aligns with neuromodulation techniques to alleviate discomfort without surgical intervention.
This device is supplied as a reusable medical instrument and is regulated under FDA 510(k) clearance (K782075) with a decision dated December 14, 1978. It was reviewed by the Neurology Advisory Committee and classified as substantially equivalent to a predicate device. The Stimulator, Model 7727 operates in clinical settings such as neurology departments, where it is used for transcutaneous application. No specific sterility or single-use requirements are noted in the regulatory data, though standard medical device hygiene protocols apply. The device’s classification under Class II—Special Controls ensures compliance with FDA-mandated performance standards for nerve stimulators.
Other devices from Medtronic Vascular, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Stimulator, Model 7727, used for?
The Stimulator, Model 7727 is designed for pain relief through transcutaneous nerve stimulation. It works by delivering controlled electrical impulses to targeted nerve pathways on the skin, modulating pain signals without requiring surgical intervention. This makes it suitable for managing chronic or acute pain in clinical settings like neurology departments.
How is the Stimulator, Model 7727 supplied and intended for use?
The Stimulator, Model 7727 is supplied as a reusable medical instrument. It is intended for clinical use in settings such as neurology departments, where it is applied transcutaneously (through the skin) to provide therapeutic electrical stimulation for pain management. Standard medical device hygiene protocols should be followed during use.
Is the Stimulator, Model 7727 single-use or reusable?
The Stimulator, Model 7727 is classified as a reusable device. While no specific sterility requirements are explicitly noted in the regulatory data, it is subject to standard medical device hygiene protocols to ensure safe reuse in clinical environments.
What regulatory pathway does the Stimulator, Model 7727 follow?
The Stimulator, Model 7727 received FDA clearance under the 510(k) pathway, specifically Traditional clearance with the designation K782075. It was reviewed by the Neurology Advisory Committee and determined to be substantially equivalent to a predicate device, ensuring compliance with FDA-mandated performance standards for nerve stimulators.
Where can the Stimulator, Model 7727 be used clinically?
This device is primarily intended for use in clinical settings such as neurology departments. Its transcutaneous application allows for non-invasive neuromodulation, making it suitable for pain management in environments where electrical stimulation is administered under medical supervision.