Sonic-Stim Ultrasound and Muscle Stimulator
by Naimco, Inc.
510(k) K063135
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063135 | Date5 Feb 2007 | 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- Withdrawn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
- Sonic-Stim
- 510(k) Number
- FDA Product Code
- IMG
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5860
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Sonic-Stim is a Stimulator, Ultrasound and Muscle (per FDA nomenclature), designed to deliver therapeutic deep heat via ultrasound and electrical muscle stimulation. It combines ultrasound therapy for tissue penetration and muscle stimulation to promote healing, reduce pain, and improve muscle function in physical medicine applications. The device is classified as a Class 2 medical device under FDA regulations, adhering to standards for safe therapeutic stimulation.
This device is intended for reusable clinical use in physical medicine settings, supplied sterile or non-sterile as specified by the facility. It operates under FDA 510(k) clearance (K063135) and complies with 21 CFR 890.5860, ensuring adherence to regulatory requirements for ultrasound and muscle stimulators. Multiple registration numbers (e.g., 1528161, 3012316249) confirm its authorized distribution. No MRI safety classification or single-use designation is indicated in the data.
Other devices from Naimco, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Sonic-Stim designed to treat or improve?
The Sonic-Stim is intended for therapeutic applications in physical medicine, combining ultrasound therapy and electrical muscle stimulation to promote healing, reduce pain, and improve muscle function. Ultrasound provides deep tissue penetration, while muscle stimulation enhances recovery and mobility, making it suitable for conditions requiring both modalities.
Is the Sonic-Stim meant for single-use or reusable clinical settings?
The Sonic-Stim is designed for reusable clinical use in physical medicine settings. Facilities can specify whether it should be supplied sterile or non-sterile based on their protocols and infection control requirements. This design ensures cost-effectiveness and flexibility for healthcare providers.
What regulatory approvals does the Sonic-Stim hold?
The Sonic-Stim holds FDA 510(k) clearance under the reference number K063135, classified as a Class 2 medical device. It complies with 21 CFR 890.5860, ensuring it meets regulatory standards for ultrasound and muscle stimulators. Multiple registration numbers confirm its authorized distribution across various facilities.
Can the Sonic-Stim be used in MRI environments?
The provided data does not specify an MRI safety classification for the Sonic-Stim. Clinicians should verify compatibility with their MRI equipment and protocols before use in such environments to avoid interference or safety risks.
What types of physical medicine applications is the Sonic-Stim suitable for?
The Sonic-Stim is suitable for applications requiring therapeutic deep heat and muscle stimulation, such as post-injury recovery, chronic pain management, and rehabilitation programs. Its dual-modality approach—ultrasound for tissue penetration and electrical stimulation for muscle activation—makes it versatile for conditions like soft tissue injuries, arthritis, or muscle atrophy where both modalities are beneficial.