510(k) Report

FDA applicant

Biomedical Life Systems, Inc.

Vista, CA37 decisions1984–20180 recalls

FDA records 37 decisions for Biomedical Life Systems, Inc. (Vista, CA) from 1984 to 2018: 37 510(k) clearances. Most are in product codes GZJ (Stimulator, Nerve, Transcutaneous, For Pain…) and IPF (Stimulator, Muscle, Powered). No recall is linked to its devices.

FDA’s records also spell it “Biomedical Life Systems”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Biomedical Life Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2011: 12018: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biomedical Life Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief22decisions
  • IPFStimulator, Muscle, Powered7decisions
  • LIHInterferential Current Therapy5decisions
  • NUHStimulator, Nerve, Transcutaneous, Over-The-Counter2decisions
  • GZBStimulator, Spinal-Cord, Implanted (Pain Relief)1decision

Who builds on its devices?

Later devices cite its devices 12 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K010749Electro Neuromuscular Stimulator, Model NMS-DigitalBiomedical Life Systems, Inc. · 20014cite it
  • K102051Pain BuddyBiomedical Life Systems, Inc. · 20112cite it
  • K031427Electro Neuromuscular Stimulator, Model BMLS03-1Biomedical Life Systems, Inc. · 20031cites it
  • K061476Electro-Nerve Stimulator Tens, Model BMLS06-1Biomedical Life Systems, Inc. · 20061cites it
  • K915210Electro-Nerve Stimulator Tens Model Micro Plus-aBiomedical Life Systems, Inc. · 19921cites it
  • K033455Electro-Nerve Stimulator Tens, Model BMLS03-5Biomedical Life Systems, Inc. · 20041cites it

What has FDA decided for it lately?

  • K172971BMLS16-1Biomedical Life Systems, Inc. · 2018
  • K102051Pain BuddyBiomedical Life Systems, Inc. · 2011
  • K061476Electro-Nerve Stimulator Tens, Model BMLS06-1Biomedical Life Systems, Inc. · 2006
  • K042711Model BMLS03-7Biomedical Life Systems, Inc. · 2005
  • K041388Combination Powered Electrical Muscle Stimulator and Interferential Stimulator, Model BMLS04-1Biomedical Life Systems, Inc. · 2004
  • K040007Interferential Stimulator, Model BMLS02-6Biomedical Life Systems, Inc. · 2004
  • K033174BMLS03-3Biomedical Life Systems, Inc. · 2004
  • K040824Interferential Stimulator, Model BMLS03-6Biomedical Life Systems, Inc. · 2004

All 35 as Biomedical Life Systems, Inc. →All 2 as Biomedical Life Systems →