Guangzhou Xinbo Electronic Co., Ltd.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Guangzhou Xinbo Electronic Co., Ltd.” (first 2017, latest 2024), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 276 days. Since 2017 the median was 276 days, against 138 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 271 |
| 2018 | 1 | 210 |
| 2019 | 0 | — |
| 2020 | 2 | 378 |
| 2021 | 4 | 323 |
| 2022 | 0 | — |
| 2023 | 2 | 106 |
| 2024 | 2 | 346 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Guangzhou Xinbo Electronic Co., Ltd. took a median 276 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 138 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GXY | Electrode, Cutaneous | 5 | 5 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 4 | 4 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 2 | 2 |
| GYB | Media, Electroconductive | 1 | 1 |
Review panels
- Neurology (8)
- Physical Medicine (4)
Most recent Guangzhou Xinbo Electronic Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230711 | Pain Therapy Device(Model: P.T.S-X) | NGX | 2024-05-16 | 428 |
| K231789 | Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII) | NGX | 2024-03-11 | 265 |
| K231167 | Conductive Silicone Rubber Electrode | GXY | 2023-08-09 | 106 |
| K231164 | Conductive carbon film electrode | GXY | 2023-08-09 | 106 |
| K202671 | DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) | NUH | 2021-11-12 | 424 |
| K212948 | Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I) | NGX | 2021-11-01 | 46 |
| K202636 | Metallic Fabric Electrodes | GXY | 2021-08-16 | 339 |
| K202638 | Pain Therapy Device | NGX | 2021-07-15 | 307 |
| K200402 | DR-HO'S Electro Therapy Conductive Gel | GYB | 2020-11-25 | 280 |
| K190118 | Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III) | GXY | 2020-05-13 | 475 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Guangzhou Xinbo Electronic Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Guangzhou Wondfo Biotech Co., Ltd. (43 510(k)s)
- Guangzhou Red Pine Medical Instrument Co., Ltd. (10 510(k)s)
- Guangzhou Decheng Biotechnology Co., Ltd. (8 510(k)s)
- Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. (7 510(k)s)
- Guangzhou Berrcom Medical Device Co., Ltd. (6 510(k)s)
- Guangzhou Longest Science & Technology Co., Ltd. (6 510(k)s)
- Guangzhou Heygears IMC., Inc. (4 510(k)s)
- Guangzhou Ajax Medical Equipment Co., Ltd. (3 510(k)s)
- Guangzhou Finecure Medical Equipment Co.,Ltd (3 510(k)s)
- Guangzhou Longest Medical Technology Co., Ltd. (3 510(k)s)
- Guangzhou Sonostar Technologies Co., Ltd. (3 510(k)s)
- Guangzhou Chemicals Import & Export Corp. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Guangzhou Xinbo Electronic Co., Ltd.?
FDA lists 12 510(k) clearances under the applicant name “Guangzhou Xinbo Electronic Co., Ltd.” (first 2017, latest 2024), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Guangzhou Xinbo Electronic Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Guangzhou Xinbo Electronic Co., Ltd. is 276 days. Since 2017: 276 days, versus 138 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Guangzhou Xinbo Electronic Co., Ltd.?
The most frequent FDA product codes under this applicant name are GXY (Electrode, Cutaneous, 5); NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 4); NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter, 2).
Next steps
- See all 12 Guangzhou Xinbo Electronic Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GXY, Guangzhou Xinbo Electronic Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.