Shenzhen Roundwhale Technology Co. , Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Shenzhen Roundwhale Technology Co. , Ltd.” (first 2018, latest 2024), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 111 days. Since 2017 the median was 111 days, against 135 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 |
|---|---|---|
| 2018 | 2 | 64 |
| 2019 | 1 | 88 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 172 |
| 2024 | 2 | 180 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shenzhen Roundwhale Technology Co. , Ltd. took a median 111 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 135 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 3 | 3 |
| GXY | Electrode, Cutaneous | 2 | 2 |
| IPF | Stimulator, Muscle, Powered | 2 | 2 |
Review panels
- Neurology (5)
- Physical Medicine (2)
Most recent Shenzhen Roundwhale Technology Co. , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231423 | Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500) | NUH | 2024-01-22 | 250 |
| K232995 | Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe | GXY | 2024-01-11 | 111 |
| K231440 | Combo Electrotherapy Device | IPF | 2023-11-03 | 169 |
| K222252 | Self-adhesive Electrode | GXY | 2023-01-19 | 176 |
| K192087 | Combo Electrotherapy Device | NUH | 2019-11-01 | 88 |
| K181688 | R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator | IPF | 2018-09-07 | 73 |
| K180956 | Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator | NUH | 2018-06-07 | 56 |
Recalls
openFDA lists no recalls under a recalling firm named Shenzhen Roundwhale Technology 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.
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (159 510(k)s)
- Shenzhen Dongdixin Technology Co., Ltd. (26 510(k)s)
- Shenzhen Kaiyan Medical Equipment Co., Ltd. (24 510(k)s)
- Shenzhen TPH Technology Co., Ltd. (24 510(k)s)
- Shenzhen Ulike Smart Electronics Co., Ltd. (23 510(k)s)
- Shenzhen AOJ Medical Technology Co., Ltd. (17 510(k)s)
- Shenzhen Beacon Display Technology Co., Ltd. (17 510(k)s)
- Shenzhen Med-Link Electronics Tech Co., Ltd. (14 510(k)s)
- Shenzhen Root Innovation Technology Co., Ltd. (13 510(k)s)
- Shenzhen Osto Technology Company Limited (12 510(k)s)
- Shenzhen RF Tech Co., Ltd. (12 510(k)s)
- Shenzhen Creative Industry Co., Ltd. (11 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shenzhen Roundwhale Technology Co. , Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Shenzhen Roundwhale Technology Co. , Ltd.” (first 2018, latest 2024), across 3 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 Shenzhen Roundwhale Technology Co. , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shenzhen Roundwhale Technology Co. , Ltd. is 111 days. Since 2017: 111 days, versus 135 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shenzhen Roundwhale Technology Co. , Ltd.?
The most frequent FDA product codes under this applicant name are NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter, 3); GXY (Electrode, Cutaneous, 2); IPF (Stimulator, Muscle, Powered, 2).
Next steps
- See all 7 Shenzhen Roundwhale Technology Co. , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NUH, Shenzhen Roundwhale Technology 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.