510(k) Report

FDA applicant

Shenzhen Osto Technology Company Limited

Shenzhen, CN12 decisions2014–20220 recalls

FDA records 12 decisions for Shenzhen Osto Technology Company Limited (Shenzhen, CN) from 2014 to 2022: 12 510(k) clearances. Most are in product codes NUH (Stimulator, Nerve, Transcutaneous…) and NGX (Stimulator, Muscle, Powered, For Muscle…). Since 2016 its 510(k)s took a median of 288 days from receipt to decision, against 198 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 11 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Shenzhen Osto Technology Co., Ltd.”.

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 Shenzhen Osto Technology Company Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2014: 12018: 32019: 22020: 12021: 42022: 1
2014high 4 (2021) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Shenzhen Osto Technology Company Limited by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NUHStimulator, Nerve, Transcutaneous, Over-The-Counter10decisions
  • NGXStimulator, Muscle, Powered, For Muscle Conditioning1decision
  • OLPOver-The-Counter Powered Light Based Laser For Acne1decision

How long do its 510(k) reviews take?

Since 2016, its 11 510(k)s took a median of 288 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 198 days; 4 of its 11 were faster than that.

Whose devices does it build on?

Its devices cite 17 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 26 times; 11 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.

  • K133929Health Expert Elctronic StimulatorShenzhen Osto Technology Company Limited · 201415cite it
  • K190783Health Expert Electronic Stimulator (model: AST-300L)Shenzhen Osto Technology Company Limited · 20205cite it
  • K172897Neck Care Therapy, Model: SYK 509BShenzhen Osto Technology Co., Ltd. · 20183cite it
  • K211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)Shenzhen Osto Technology Company Limited · 20211cites it
  • K210756Neck Care Therapy, Model: AST-905A, AST-905D, AST-905HShenzhen Osto Technology Company Limited · 20211cites it
  • K190673Health Expert Electronic StimulatorShenzhen Osto Technology Company Limited · 20191cites it

What has FDA decided for it lately?

  • K213056LED Facial MaskShenzhen Osto Technology Company Limited · 2022
  • K211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)Shenzhen Osto Technology Company Limited · 2021
  • K212989Low-frequency Stimulator (Model: AST-645, AST-646)Shenzhen Osto Technology Co., Ltd. · 2021
  • K211736Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)Shenzhen Osto Technology Company Limited · 2021
  • K210756Neck Care Therapy, Model: AST-905A, AST-905D, AST-905HShenzhen Osto Technology Company Limited · 2021
  • K190783Health Expert Electronic Stimulator (model: AST-300L)Shenzhen Osto Technology Company Limited · 2020
  • K190673Health Expert Electronic StimulatorShenzhen Osto Technology Company Limited · 2019
  • K182136Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)Shenzhen Osto Technology Co., Ltd. · 2019

All 7 as Shenzhen Osto Technology Company Limited →All 5 as Shenzhen Osto Technology Co., Ltd. →