510(k) Report

FDA applicant

Life Enhancement Technologies, LLC

Bethesda, MD3 decisions1989–19900 recalls

FDA records 3 decisions for Life Enhancement Technologies, LLC (Bethesda, MD) from 1989 to 1990: 3 510(k) clearances. Most are in product codes ILO (Pack, Hot Or Cold, Water Circulating) and FLF (Sterilizer, Ethylene-Oxide Gas). No recall is linked to its devices.

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

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Life Enhancement Technologies, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Life Enhancement Technologies, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Life Enhancement Technologies, LLC 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?

  • ILOPack, Hot Or Cold, Water Circulating2decisions
  • FLFSterilizer, Ethylene-Oxide Gas1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K873200Karlson Ozone Sterilizer Model 100BLife Enhancement Technologies, LLC · 19891cites it

What has FDA decided for it lately?

  • K900356Thermoaire Splint (TM) (Tas)Life Enhancement Technologies, LLC · 1990
  • K900355Mark Vii Thermoregulation Assist SystemLife Enhancement Technologies, LLC · 1990
  • K873200Karlson Ozone Sterilizer Model 100BLife Enhancement Technologies, LLC · 1989

All 3 as Life Enhancement Technologies, LLC →