Identifiers
- 510(k) Number
- K033174 FDA 510(k)
- FDA Product Code
- IPF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5850 FDA 510(k)
- Regulation Number
- 890.5850 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BMLS03-3 is a portable, battery-powered neuromuscular stimulator designed to deliver electrical stimulation for therapeutic purposes. Classified under product code IPF (Infrared Phototherapy and Physical Medicine Devices), it generates symmetrical or asymmetrical biphasic rectangular waveforms to modulate nerve and muscle activity. This device is intended for controlled electrical stimulation of muscles and nerves, aiding in therapeutic interventions such as spasm relaxation and circulation enhancement. Its four-channel configuration allows simultaneous stimulation across multiple treatment sites.
The BMLS03-3 is supplied as a reusable medical device, requiring proper maintenance and cleaning per manufacturer guidelines. It operates on battery power, ensuring portability for clinical or home use. The device holds FDA 510(k) clearance (K033174) under the Physical Medicine advisory committee, confirming its compliance with U.S. regulatory standards. No specific sterility or MRI safety information is provided in the available data, and its intended use is limited to neuromuscular stimulation as described in the submitted specifications.
Frequently asked questions
What is the BMLS03-3 neuromuscular stimulator used for?
The BMLS03-3 is designed to provide controlled electrical stimulation of muscles and nerves for therapeutic purposes. Its primary applications include spasm relaxation and enhancing circulation. The device achieves this through symmetrical or asymmetrical biphasic rectangular waveforms, which modulate nerve and muscle activity. The four-channel configuration allows simultaneous treatment across multiple sites, making it versatile for clinical or home use.
Is the BMLS03-3 a single-use or reusable device?
The BMLS03-3 is classified as a reusable medical device. As such, it requires regular maintenance and cleaning according to the manufacturer’s guidelines to ensure proper functionality and hygiene. Unlike single-use devices, this model is intended for repeated use in clinical or home settings, provided it is properly cared for.
How is the BMLS03-3 powered, and is it portable?
Yes, the BMLS03-3 is battery-powered, which enables its portability for use in clinical settings or at home. The portable design allows clinicians or patients to administer neuromuscular stimulation without being tethered to a power outlet, increasing flexibility in treatment environments.
Does the BMLS03-3 come with any sterility guarantees?
The available data does not specify any sterility guarantees for the BMLS03-3. Since it is a reusable device, sterility is not applicable in the same way as single-use items. Proper cleaning and maintenance per manufacturer instructions are essential to ensure safe and effective use. If sterility is a concern for a specific procedure, additional precautions may be required.
What regulatory approval does the BMLS03-3 hold?
The BMLS03-3 holds FDA 510(k) clearance under the product code IPF (Infrared Phototherapy and Physical Medicine Devices). The clearance (K033174) was granted by the Physical Medicine advisory committee in 2004, confirming its substantial equivalence to a predicate device. This approval ensures compliance with U.S. regulatory standards for neuromuscular stimulators.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BMLS03-3 by BIOMEDICAL LIFE SYSTEMS, INC. | FDA 510(k) Summary, Bio Medical Life Systems - Medical Products & Accessories, BMLS03-3 (K033174) — FDA 510 (k) | Innolitics, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K033174 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomedical Life Systems, Inc.
Sources (1)
- FDA 510(k) K033174 24 fields · synced Oct 1, 2026