510(k) Report

FDA applicant

Shanghai Bangbang Robotics Co., Ltd.

Shanghai, CN4 decisions2023–20260 recalls

FDA records 4 decisions for Shanghai Bangbang Robotics Co., Ltd. (Shanghai, CN) from 2023 to 2026: 4 510(k) clearances. All are in product code ITI (Wheelchair, Powered). Since 2016 its 510(k)s took a median of 128 days from receipt to decision, against 127 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 3 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, physical medicine panel, where it files most

How often FDA has decided Shanghai Bangbang Robotics Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2023: 22024: 12026 (partial year): 1
2023high 2 (2023) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Shanghai Bangbang Robotics Co., Ltd. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shanghai Bangbang Robotics Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • ITIWheelchair, Powered4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 128 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 127 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K231868Electric Wheelchair (Robooter E40), Model name: BBR-E40-01Shanghai Bangbang Robotics Co., Ltd. · 20232cite it
  • K223393Electric WheelchairShanghai Bangbang Robotics Co., Ltd. · 20231cites it

What has FDA decided for it lately?

  • K253276Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02)Shanghai Bangbang Robotics Co., Ltd. · 2026
  • K240339Electric Wheelchair (Robooter E60) (BBR-E60-01); Electric Wheelchair (Robooter E60) (BBR-E60-02); Electric…Shanghai Bangbang Robotics Co., Ltd. · 2024
  • K231868Electric Wheelchair (Robooter E40), Model name: BBR-E40-01Shanghai Bangbang Robotics Co., Ltd. · 2023
  • K223393Electric WheelchairShanghai Bangbang Robotics Co., Ltd. · 2023

All 4 as Shanghai Bangbang Robotics Co., Ltd. →