ThermaStim
510(k) K962703
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK962703 | Date21 Feb 1997 | 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- Withdrawn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
- Thee Thermastim
- 510(k) Number
- FDA Product Code
- IMJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5290
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The ThermaStim is a nonthermal shortwave diathermy device classified as a Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat under FDA nomenclature. It delivers pulsed electromagnetic energy at frequencies of 13.56 MHz or 27.12 MHz for adjunctive therapeutic applications, excluding heat generation within body tissues.
This device is intended for prescription use in physical medicine settings and operates as a Class II medical device under FDA regulations. It is supplied as a reusable therapeutic modality, with no indication of sterility requirements or MRI compatibility in its specifications. Authorized under FDA 510(k) clearance (K962703), it adheres to the IMJ product code and was originally submitted in 1996 for substantially equivalent review by the Physical Medicine Advisory Committee.
Other devices from Ehti Medical Corp.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the ThermaStim device in clinical settings?
The ThermaStim is designed as a nonthermal shortwave diathermy device, delivering pulsed electromagnetic energy at 13.56 MHz or 27.12 MHz for adjunctive therapeutic applications. It is specifically intended to provide deep heat to tissues without generating heat directly within the body, making it useful in physical medicine settings for conditions where controlled tissue stimulation is beneficial.
Is the ThermaStim device single-use or reusable, and what does that mean for maintenance?
The ThermaStim is supplied as a reusable therapeutic modality, meaning it is not intended for single-use disposal. This classification implies that the device requires regular cleaning, maintenance, and potential calibration to ensure consistent performance and safety over repeated use in clinical environments.
What frequency options are available for the ThermaStim, and how might they influence treatment selection?
The ThermaStim operates at two frequency settings: 13.56 MHz and 27.12 MHz. These frequencies allow clinicians to tailor the device’s electromagnetic energy delivery to specific tissue depths or therapeutic goals, though the device itself does not generate heat within the body. The choice of frequency may depend on factors like the targeted anatomical area or the desired depth of tissue interaction.
How is the ThermaStim regulated, and what does its classification as a Class II device entail?
The ThermaStim is classified as a Class II medical device under FDA regulations and has received 510(k) clearance (K962703) for substantial equivalence. This classification means it undergoes special controls to ensure its safety and effectiveness, including performance standards and post-market surveillance, but it does not require pre-market approval. The device was originally reviewed by the Physical Medicine Advisory Committee in 1996.
Are there any special storage requirements for the ThermaStim, such as environmental conditions or handling?
The provided specifications do not explicitly mention sterility requirements or environmental storage conditions for the ThermaStim. However, as a reusable device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to prevent damage. Proper maintenance protocols, such as regular cleaning and calibration, will also be critical to ensure its longevity and performance.