Guangzhou Longest Science & Technology Co., Ltd.: FDA clearances and approvals
Guangzhou Longest Science & Technology Co., Ltd. has 6 FDA 510(k) clearances (first 2019, latest 2021), across 5 product codes in 3 review panels. Median 510(k) review time: 259 days. Since 2017 its median was 259 days, against 137 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 2 | 188 |
| 2020 | 3 | 252 |
| 2021 | 1 | 463 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Guangzhou Longest Science & Technology Co., Ltd.'s cleared 510(k)s took a median 259 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 137 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 2 | 2 |
| GZI | Stimulator, Neuromuscular, External Functional | 1 | 1 |
| IRP | Massager, Powered Inflatable Tube | 1 | 1 |
| JOW | Sleeve, Limb, Compressible | 1 | 1 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 1 | 1 |
Review panels
- Physical Medicine (3)
- Neurology (2)
- Cardiovascular (1)
Most recent Guangzhou Longest Science & Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202110 | MStim Drop Model: LGT-233 | GZI | 2021-11-05 | 463 |
| K201845 | Portable Electro-Stimulation Therapy Device, Model: LGT-232(US) | NGX | 2020-10-08 | 94 |
| K182020 | Portable Electro-Stimulation Therapy Device | NGX | 2020-09-17 | 783 |
| K191856 | Compression Therapy Device | JOW | 2020-03-19 | 252 |
| K191862 | Compression Therapy Device Model LGT-2200SP | IRP | 2019-10-29 | 110 |
| K182108 | Portable Electro-Stimulation Therapy Device | NUH | 2019-04-26 | 266 |
Recalls
openFDA lists no recalls under a recalling firm named Guangzhou Longest Science & Technology Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Guangzhou Longest Science & Technology Co., Ltd. have?
Guangzhou Longest Science & Technology Co., Ltd. has 6 FDA 510(k) clearances (first 2019, latest 2021), across 5 product codes in 3 review panels.
How long does FDA take to clear Guangzhou Longest Science & Technology Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Guangzhou Longest Science & Technology Co., Ltd.'s cleared 510(k)s is 259 days. Since 2017: 259 days, versus 137 days for all cleared 510(k)s in the same product codes.
What devices does Guangzhou Longest Science & Technology Co., Ltd. make?
Its most frequent FDA product codes are NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 2); GZI (Stimulator, Neuromuscular, External Functional, 1); IRP (Massager, Powered Inflatable Tube, 1).
Has Guangzhou Longest Science & Technology Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Guangzhou Longest Science & Technology Co., Ltd. Related entities may recall under other names.
Next steps
- See all 6 Guangzhou Longest Science & Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NGX, Guangzhou Longest Science & Technology Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.