Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Chongqing Rob Linka Science and Technology Co., Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233067 | Wireless TENS & EMS (Model SM9110,SM9113,SM9116) | Chongqing Rob Linka Science and Technology Co., Ltd. | 2024-07-19 | 297 | 0 |
| K233070 | Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566, | Chongqing Rob Linka Science and Technology Co., Ltd. | 2024-03-13 | 169 | 0 |
| K233092 | Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) | Chongqing Rob Linka Science and Technology Co., Ltd. | 2024-02-12 | 139 | 0 |
| K230829 | TENS7000 Rechargeable (Model:TENS7000 Rechargeable) | Chongqing Rob Linka Science and Technology Co., Ltd. | 2023-04-26 | 30 | 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