Data / Medical devices / United States / BioMedical Life Systems Inc.
BioMedical Life Systems Inc.: FDA-registered device maker in Carlsbad, CA, United States, 9 510(k) clearances
BioMedical Life Systems Inc. is registered with the FDA (registration 2024292) in Carlsbad, CA, United States. It lists 4 device types. The FDA files 9 510(k) clearances under its listings, the newest dated July 29, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2024292
- Address
- 1954 Kellogg Avenue, Carlsbad, CA, United States, 92008
- Owner or operator
- BioMedical Life Systems Inc. (10027823)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- December 4, 2008
- Registered through
- 2026
- Brand names listed
- BioMed 2000 XT, BioStim INF, BioStim NMS2, EMS 2000, GV350, Impulse 3000 T, Impulse 3000T, Micro Plus and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Interferential Current Therapy | LIH | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 29, 2011 | K102051 | PAIN BUDDY | NUH | Substantially Equivalent | Biomedical Life Systems, Inc. | accessdata.fda.gov |
| July 26, 2006 | K061476 | ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1 | GZJ | Substantially Equivalent | Biomedical Life Systems, Inc. | accessdata.fda.gov |
| November 23, 2004 | K041388 | COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1 | GZJ | Substantially Equivalent | Biomedical Life Systems, Inc. | accessdata.fda.gov |
| April 29, 2004 | K040824 | INTERFERENTIAL STIMULATOR, MODEL BMLS03-6 | LIH | Substantially Equivalent | Biomedical Life Systems, Inc. | accessdata.fda.gov |
| January 15, 2004 | K033455 | ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5 | GZJ | Substantially Equivalent | Biomedical Life Systems, Inc. | accessdata.fda.gov |
| August 19, 2003 | K031427 | ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1 | IPF | Substantially Equivalent | Biomedical Life Systems, Inc. | accessdata.fda.gov |
| January 7, 1994 | K932916 | GALVANIC GENERATOR MODEL IMF4150/A | IPF | Substantially Equivalent | Biomedical Life Systems, Inc. | accessdata.fda.gov |
| May 4, 1992 | K915210 | ELECTRO-NERVE STIMULATOR TENS MODEL MICRO PLUS-A | GZJ | Substantially Equivalent | Biomedical Life Systems, Inc. | accessdata.fda.gov |
| November 6, 1989 | K884651 | ELECTRO NEUROMUSCULAR STIMULATOR MODEL 2000 | IPF | Substantially Equivalent | Biomedical Life Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Muscle, Powered
- All makers of Interferential Current Therapy
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
Updated July 29, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.