SD-605 SD II Program
510(k) K923935
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK923935 | Date15 Oct 1992 | 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- Withdrawn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, 20 Sep 2026
The SD-605 SD II Program is a transcutaneous electrical nerve stimulator (TENS) device, classified under product code GZJ. It delivers controlled electrical impulses through electrodes placed on the skin to modulate pain signals, providing non-invasive pain relief for neurological conditions.
This device is intended for single-use or reusable applications in clinical or home settings, depending on manufacturer guidelines. Supplied as a sterile or non-sterile unit, it adheres to FDA 510(k) clearance (K923935) under the Neurology advisory committee, with no explicit MRI safety restrictions noted. Storage conditions and reusability are not detailed in the regulatory submission, but compliance with FDA 510(k) standards applies. No additional regulatory approvals beyond the 1992 clearance are referenced.
Other devices from Skylark Device Co., Ltd.
Questions
AI-generated answers, 20 Sep 2026
What types of neurological conditions is the SD-605 SD II Program designed to help manage through pain relief?
The SD-605 SD II Program is a transcutaneous electrical nerve stimulator (TENS) device intended to provide non-invasive pain relief for neurological conditions by delivering controlled electrical impulses through electrodes placed on the skin. It modulates pain signals to alleviate discomfort, though the specific conditions it targets are not detailed beyond its general indication for pain management in neurological cases.
Is the SD-605 SD II Program meant for single-use or can it be reused, and how should it be handled if reused?
The device is designed for either single-use or reusable applications, depending on the manufacturer’s guidelines. While the regulatory submission does not specify storage conditions or reuse protocols, compliance with FDA 510(k) standards applies. Clinicians should follow Skylark Device Co., Ltd.’s instructions for proper cleaning, maintenance, and sterilization if reuse is intended.
How is the SD-605 SD II Program supplied, and does it come in sterile or non-sterile packaging?
The device is supplied as either a sterile or non-sterile unit, but the regulatory data does not specify which configurations are available or under what circumstances. The choice depends on the clinical setting (e.g., hospital vs. home use) and manufacturer recommendations, which should be consulted for precise details.
What regulatory pathway did the SD-605 SD II Program follow to gain clearance, and which advisory committee was involved?
The SD-605 SD II Program received FDA clearance through a Traditional 510(k) pathway (K923935) under the Neurology advisory committee (NE). The device was deemed substantially equivalent to a predicate, with clearance granted on October 15, 1992. No additional regulatory approvals beyond this clearance are referenced in the submission.
Are there any known restrictions on using the SD-605 SD II Program near MRI machines, or should patients avoid MRI scans while using it?
The regulatory submission does not explicitly mention MRI safety restrictions for the SD-605 SD II Program. However, since it involves electrical components and electrodes, clinicians should verify with Skylark Device Co., Ltd. or consult MRI safety guidelines before use in or near MRI environments to avoid potential interference or hazards.