SRT II Muscle Stimulator
by Therapeutic Innovations, Inc.
510(k) K071677
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK071677 | Date11 Jul 2008 | 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- Withdrawn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
- IPF
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The SRT II Muscle Stimulator is a physical medicine device classified under the Product Code IPF. It is designed to deliver electrical stimulation to muscles for therapeutic purposes, aiding in muscle re-education, strengthening, and pain management through controlled electrical impulses. This device is intended for use by trained professionals in clinical settings to assist patients with neuromuscular conditions or post-injury rehabilitation. Its functionality relies on hardware with embedded software for precise control of stimulation parameters.
The SRT II Muscle Stimulator is supplied as a reusable device and is intended for use in clinical environments such as physical therapy clinics or rehabilitation centers. It requires no sterilization as it is not intended for invasive procedures, but proper cleaning and maintenance are necessary to ensure functionality and hygiene. The device holds an FDA 510(k) clearance (K071677) under the Traditional review pathway, with a clearance date of July 11, 2008. No specific MRI safety information is provided, and its operation is governed by regulatory standards applicable to electrical stimulation devices in physical medicine.
Questions
AI-generated answers, 1 Oct 2026
What is the SRT II Muscle Stimulator used for?
The SRT II Muscle Stimulator is designed to deliver controlled electrical impulses to muscles, helping with muscle re-education, strengthening, and pain management. It is specifically intended for use by trained professionals in clinical settings, such as physical therapy clinics or rehabilitation centers, to assist patients recovering from neuromuscular conditions or injuries.
Is the SRT II Muscle Stimulator reusable or single-use?
The SRT II Muscle Stimulator is a reusable device. It is intended for use in clinical environments and requires proper cleaning and maintenance to ensure functionality and hygiene, though it does not need sterilization as it is not intended for invasive procedures.
What regulatory clearance does the SRT II Muscle Stimulator hold?
The SRT II Muscle Stimulator holds an FDA 510(k) clearance (K071677) under the Traditional review pathway. This clearance was granted on July 11, 2008, and the device is classified under Product Code IPF for physical medicine applications.
Does the SRT II Muscle Stimulator have any specific MRI safety information?
No specific MRI safety information is provided for the SRT II Muscle Stimulator. Users should follow standard guidelines for electrical stimulation devices in physical medicine when considering MRI compatibility.
How is the SRT II Muscle Stimulator controlled and operated?
The SRT II Muscle Stimulator operates using hardware with embedded software, allowing for precise control of stimulation parameters. This ensures accurate delivery of electrical impulses tailored to therapeutic needs.