Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Roundwhale Technology Co. , Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
111 daysmedian FDA review time
250 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231423 | Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C10 | Shenzhen Roundwhale Technology Co. , Ltd. | 2024-01-22 | 250 | 0 |
| K232995 | Neurological Therapy Devices - Accessories: Electrotherapy d | Shenzhen Roundwhale Technology Co. , Ltd. | 2024-01-11 | 111 | 0 |
| K231440 | Combo Electrotherapy Device | Shenzhen Roundwhale Technology Co. , Ltd. | 2023-11-03 | 169 | 0 |
| K222252 | Self-adhesive Electrode | Shenzhen Roundwhale Technology Co. , Ltd. | 2023-01-19 | 176 | 0 |
| K192087 | Combo Electrotherapy Device | Shenzhen Roundwhale Technology Co. , Ltd. | 2019-11-01 | 88 | 0 |
| K181688 | R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TEN | Shenzhen Roundwhale Technology Co. , Ltd. | 2018-09-07 | 73 | 0 |
| K180956 | Electrical Stimulator - Model R-C1 TENS and EMS stimulator, | Shenzhen Roundwhale Technology Co. , Ltd. | 2018-06-07 | 56 | 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