Bio SDP (Saturn SD, GLC-III SD, Stat-SD)
510(k) K934051
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK934051 | Date11 Jul 1994 | 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- Withdrawn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
- Bio Sdp (Aka Saturn Sd, Glc-III Sd & Stat-Sd)
- 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 Bio SDP is a Transcutaneous Nerve Stimulator, designed for pain relief by delivering electrical impulses to peripheral nerves via surface electrodes. It falls under the classification of a Class II medical device, regulated under the FDA’s 510(k) pathway for substantial equivalence to predicate devices. This device is intended for use in neurology-related applications, targeting chronic pain management through non-invasive stimulation.
The Bio SDP is supplied as a reusable device, requiring proper sterilization between uses in clinical settings. It operates under FDA clearance (510(k) K934051) and adheres to the product code GZJ for regulatory classification. No specific MRI safety or single-use designation is noted in available records, though standard electrical safety precautions apply. Storage and handling follow manufacturer guidelines to maintain device integrity.
Other devices from Skylark Device Co., Ltd.
Questions
AI-generated answers, 19 Sep 2026
Is the Bio SDP designed for single-use or can it be reused in a clinical setting?
The Bio SDP is explicitly marked as a reusable device, meaning it is intended for multiple uses in clinical settings. However, it requires proper sterilization between uses to ensure safety and effectiveness, as outlined in the manufacturer’s guidelines.
What types of pain conditions is the Bio SDP primarily intended to address?
The Bio SDP is designed for pain relief in neurology-related applications, specifically targeting chronic pain management through non-invasive electrical stimulation of peripheral nerves. It is not intended for acute pain or conditions outside this scope.
How should the Bio SDP be stored to maintain its integrity and functionality?
The Bio SDP must be stored and handled according to the manufacturer’s guidelines to preserve its integrity. While specific storage conditions are not detailed in the provided data, standard precautions for electrical medical devices—such as protection from moisture, extreme temperatures, and physical damage—should be followed.
What regulatory pathway was used for FDA clearance of the Bio SDP, and what does this mean for its use?
The Bio SDP was cleared through the FDA’s 510(k) pathway, specifically under the classification of Substantially Equivalent (SESE) to a predicate device. This means it has been determined to have the same intended use and technological characteristics as a previously cleared device, ensuring it meets FDA safety and effectiveness standards for transcutaneous nerve stimulation.
Are there any special considerations for using the Bio SDP near MRI equipment?
The provided data does not specify whether the Bio SDP is MRI-safe or unsafe. Since it is an electrical device, standard electrical safety precautions should be followed when used in proximity to MRI equipment. Clinicians should consult the manufacturer’s instructions or safety guidelines to avoid potential interference or risks.