510(k) Report

FDA applicant

Lhasa Oms, Inc.

Weymouth, MA8 decisions2005–20210 recalls

FDA records 8 decisions for Lhasa Oms, Inc. (Weymouth, MA) from 2005 to 2021: 8 510(k) clearances. Most are in product codes GZJ (Stimulator, Nerve, Transcutaneous, For Pain…) and ILY (Lamp, Infrared, Therapeutic Heating). Its devices cite 6 predicates, 1 of them its own earlier devices. 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, neurology panel, where it files most

How often FDA has decided Lhasa Oms, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007: 12021: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Lhasa”

FDA records each applicant name separately; these may or may not be the same firm.