510(k) Report

FDA applicant

American Institute of Koryo Hand Therapy

Industry, CA5 decisions1998–19980 recalls

FDA records 5 decisions for American Institute of Koryo Hand Therapy (Industry, CA) in 1998: 5 510(k) clearances. All are in product code MQX (Needle, Acupuncture, Single Use). Its devices cite 4 predicates, 0 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, general hospital panel, where it files most

How often FDA has decided American Institute of Koryo Hand Therapy’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Institute of Koryo Hand Therapy since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — American Institute of Koryo Hand Therapy 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?

  • MQXNeedle, Acupuncture, Single Use5decisions

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K980471KHT Guam Needle, Acupuncture NeedleAmerican Institute of Koryo Hand Therapy · 1998
  • K980472KHT Soft Needle, Acupuncture NeedleAmerican Institute of Koryo Hand Therapy · 1998
  • K980470KHT Soft Sooji Needle, Hand Acupuncture NeedleAmerican Institute of Koryo Hand Therapy · 1998
  • K980469KHT Sooji Needle, Hand Acupuncture NeedleAmerican Institute of Koryo Hand Therapy · 1998
  • K974527KHT Seoam Needle, Hand Acupuncture NeedleAmerican Institute of Koryo Hand Therapy · 1998

All 5 as American Institute of Koryo Hand Therapy →