Tai Sheng Neox Powered Muscle Stimulator
by Tai Sheng Electrical Machinery Co., Ltd.
510(k) K031310
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK031310 | Date12 Apr 2004 | 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- Withdrawn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
- Tai Sheng Various Neox Powered Muscle Stimulator
- 510(k) Number
- FDA Product Code
- IPF
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Tai Sheng Neox Powered Muscle Stimulator is a Class II medical device classified under the FDA’s classification name ‘Stimulator, Muscle, Powered.’ It is designed to repeatedly contract muscles through the application of electrical stimulation, aiding in physical medicine applications such as muscle re-education, pain management, or postoperative recovery. This device delivers controlled electrical impulses to stimulate neuromuscular activity, supporting therapeutic interventions for patients requiring muscle activation or rehabilitation.
The device is supplied as a powered stimulator and is intended for use in clinical or home settings under professional supervision or patient instruction. It is not specified as single-use or reusable in the regulatory data, though typical powered muscle stimulators are often reusable with appropriate cleaning and maintenance. No MRI safety information or sterility requirements are noted in the provided specifications. Authorised under FDA 510(k) clearance (K031310), it falls under the Product Code IPF and was determined substantially equivalent in 2004.
Questions
AI-generated answers, 20 Sep 2026
What types of clinical applications is the Tai Sheng Neox Powered Muscle Stimulator primarily used for?
The Tai Sheng Neox Powered Muscle Stimulator is designed for physical medicine applications such as muscle re-education, pain management, and postoperative recovery. It delivers controlled electrical impulses to stimulate neuromuscular activity, aiding in muscle activation and rehabilitation under professional supervision or patient instruction.
Is the Tai Sheng Neox Powered Muscle Stimulator intended for use in both clinical and home settings?
Yes, the device is explicitly stated as intended for use in both clinical and home settings, provided it is used under professional supervision or with proper patient instruction. This makes it versatile for therapists, physical medicine practitioners, and patients recovering at home.
How is the device classified under FDA regulations, and what does that mean for its use?
The Tai Sheng Neox is classified as a Class II medical device under the FDA’s ‘Stimulator, Muscle, Powered’ category (Product Code IPF). This classification means it undergoes a 510(k) premarket notification review to demonstrate substantial equivalence to a predicate device, ensuring it meets safety and effectiveness standards for neuromuscular stimulation in therapeutic settings.
Are there any specific cleaning or maintenance requirements mentioned for the Tai Sheng Neox?
The regulatory data does not explicitly state whether the device is single-use or reusable, but typical powered muscle stimulators in this category are often reusable with proper cleaning and maintenance. While no sterility requirements or MRI safety information are noted, users should follow manufacturer guidelines for disinfection and upkeep to ensure safe, repeated clinical or home use.