Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Guangzhou Xinbo Electronic Co., Ltd. · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
280 daysmedian FDA review time
428 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230711 | Pain Therapy Device(Model: P.T.S-X) | Guangzhou Xinbo Electronic Co., Ltd. | 2024-05-16 | 428 | 0 |
| K231789 | Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII) | Guangzhou Xinbo Electronic Co., Ltd. | 2024-03-11 | 265 | 0 |
| K231167 | Conductive Silicone Rubber Electrode | Guangzhou Xinbo Electronic Co., Ltd. | 2023-08-09 | 106 | 0 |
| K231164 | Conductive carbon film electrode | Guangzhou Xinbo Electronic Co., Ltd. | 2023-08-09 | 106 | 0 |
| K202671 | DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS- | Guangzhou Xinbo Electronic Co., Ltd. | 2021-11-12 | 424 | 0 |
| K212948 | Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S | Guangzhou Xinbo Electronic Co., Ltd. | 2021-11-01 | 46 | 0 |
| K202636 | Metallic Fabric Electrodes | Guangzhou Xinbo Electronic Co., Ltd. | 2021-08-16 | 339 | 0 |
| K202638 | Pain Therapy Device | Guangzhou Xinbo Electronic Co., Ltd. | 2021-07-15 | 307 | 0 |
| K200402 | DR-HO'S Electro Therapy Conductive Gel | Guangzhou Xinbo Electronic Co., Ltd. | 2020-11-25 | 280 | 0 |
| K190118 | Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP | Guangzhou Xinbo Electronic Co., Ltd. | 2020-05-13 | 475 | 0 |
| K172887 | XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy P | Guangzhou Xinbo Electronic Co., Ltd. | 2018-04-19 | 210 | 0 |
| K163611 | Pain Therapy Device | Guangzhou Xinbo Electronic Co., Ltd. | 2017-09-19 | 271 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda