Muscle Pain Device (MPD)
by Stevens Proof of Concept, Inc.
510(k) K073361
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK073361 | Date18 Mar 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- Withdrawn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 Muscle Pain Device (MPD) is a Stimulator, Muscle, Powered, classified under FDA Product Code IPF. It is designed to deliver controlled electrical stimulation to muscles, inducing repetitive contractions via electrodes to alleviate muscle pain or discomfort. This device operates through low-level electrical impulses to target specific muscle groups, aiding in therapeutic interventions for musculoskeletal conditions. Its primary function is to provide non-invasive relief through neuromuscular electrical stimulation (NMES).
The MPD is supplied as a reusable medical device, intended for use in clinical or home settings under professional supervision. It requires no sterility as it is not implanted or used in sterile procedures but must be cleaned and maintained per manufacturer guidelines to ensure safe operation. The device is not MRI-compatible and should not be used in magnetic resonance environments. Authorized for commercial distribution in the U.S. following FDA 510(k) clearance (K073361), it adheres to regulatory standards for powered muscle stimulators as defined by the Physical Medicine Advisory Committee.
Questions
AI-generated answers, 1 Oct 2026
What is the Muscle Pain Device (MPD) used for?
The Muscle Pain Device (MPD) is designed to provide therapeutic relief for muscle pain or discomfort by delivering controlled electrical stimulation. It works through neuromuscular electrical stimulation (NMES), inducing repetitive muscle contractions to target specific muscle groups. This approach is particularly useful for managing musculoskeletal conditions where non-invasive pain relief is desired.
Is the Muscle Pain Device (MPD) reusable or single-use?
The Muscle Pain Device (MPD) is classified as a reusable medical device. It is intended for use in both clinical and home settings, provided it is operated under professional supervision. Reusability allows for cost-effective use over time, but it requires proper cleaning and maintenance as outlined by the manufacturer to ensure safe and effective operation.
Does the Muscle Pain Device (MPD) require sterilization?
No, the Muscle Pain Device (MPD) does not require sterilization as it is not implanted or used in sterile procedures. However, it must be cleaned and maintained according to the manufacturer’s guidelines to prevent contamination and ensure safe, reliable performance. Proper care extends the device’s lifespan and maintains its functionality.
Can the Muscle Pain Device (MPD) be used in an MRI environment?
No, the Muscle Pain Device (MPD) is explicitly stated as not MRI-compatible. It should never be used in magnetic resonance environments due to potential risks associated with electromagnetic interference or damage to the device. Always verify compatibility with the local MRI facility before use.
What regulatory approval does the Muscle Pain Device (MPD) hold?
The Muscle Pain Device (MPD) has received FDA 510(k) clearance under the product code IPF, classified as a powered muscle stimulator. This clearance was granted following a review by the Physical Medicine Advisory Committee, confirming its substantial equivalence to a legally marketed predicate device. The device adheres to regulatory standards for powered muscle stimulators in the U.S.