Muscle Stimulator SA-100
by Health@Fitness Technologies, Inc.
510(k) K010807
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK010807 | Date9 Aug 2001 | 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- Withdrawn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 Muscle Stimulator SA-100 is a muscle stimulator (device type: IPF—Intermittent Pulse Frequency), designed to deliver electrical stimulation for muscle activation, rehabilitation, or pain management. It applies controlled electrical impulses to stimulate nerve and muscle tissues, aiding in muscle contraction, recovery, or therapeutic intervention. The device is classified under physical medicine applications and is intended for non-invasive use on the human body.
The Muscle Stimulator SA-100 is supplied as a reusable medical device, intended for use in clinical or home settings under professional supervision or patient self-administration. It requires no sterility as it is not implanted or invasive, but proper cleaning and maintenance are necessary to ensure hygiene. The device is FDA-cleared under 510(k) classification K010807, with a traditional review pathway, and is intended for use in physical medicine applications. No MRI safety information is specified.
Questions
AI-generated answers, 1 Oct 2026
What is the Muscle Stimulator SA-100 used for?
The Muscle Stimulator SA-100 is designed to deliver electrical stimulation for muscle activation, rehabilitation, or pain management. It works by applying controlled electrical impulses to stimulate nerve and muscle tissues, promoting muscle contraction, recovery, or therapeutic intervention. This device is classified under physical medicine applications and is intended for non-invasive use on the human body.
Is the Muscle Stimulator SA-100 a single-use or reusable device?
The Muscle Stimulator SA-100 is a reusable medical device. While it does not require sterility (as it is not invasive or implanted), proper cleaning and maintenance are essential to ensure hygiene and safe, repeated use in both clinical and home settings.
What regulatory pathway does the Muscle Stimulator SA-100 follow?
The Muscle Stimulator SA-100 is FDA-cleared under the 510(k) classification with the reference number K010807. It follows a traditional review pathway and is classified as substantially equivalent to a predicate device. The device was reviewed by the Physical Medicine (PM) Advisory Committee.
Can the Muscle Stimulator SA-100 be used in home settings?
Yes, the Muscle Stimulator SA-100 is intended for use in both clinical and home settings. However, it is designed for use under professional supervision or patient self-administration, ensuring safe and effective application for muscle activation, rehabilitation, or pain management.
Does the Muscle Stimulator SA-100 have any specific safety information regarding MRI?
The provided specifications for the Muscle Stimulator SA-100 do not include any details regarding MRI safety. Users should exercise caution and consult manufacturer guidelines or medical professionals before using the device in proximity to MRI equipment.