Joytech Healthcare Co., Ltd.
Manufacturer and brand owner in Hangzhou, Zhejiang, China. 9 device types, 34 products catalogued, 24 clearances.
Joytech Healthcare Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Wellness, Pump, Breast, Powered and 7 other device types. 33 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2017.
9device types registered with the FDA
34products catalogued under its own name
24510(k) clearances
Registration
| Registered name | JOYTECH HEALTHCARE CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013053058 |
| FEI number | 3013053058 |
| DUNS | 544392778 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 浙江健拓医疗仪器科技有限公司 |
|---|---|
| Unified social credit code | 913301000567166303 |
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | No.365, Wuzhou Road |
| Postal code | 311100 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Clinical Electronic Thermometer | Class 2 | CVS Health Multi-Tip Thermometer 65-203433(834807), Infrared Ear/Forehead Thermometer, CVS Health Infrared Non-Contact Bluetooth Thermometer 65-203428(6359910), Digital Thermometer, Medichoice 916812B, CVS Health Flexible Tip Easy Read Thermometer 65-203425(193592) and 30 more | 2025 | 49 |
| Continuous Measurement Thermometer | Class 2 | healthsmart Touchless Infrared Thermometer Item: 18-555-0000, Infrared Forehead Thermometer DET-3010DET-3011,DET-3011b,DET-3012, healthsmart Talking Infrared Ear & Forehead Thermometer Item: 18-930-000, One Step® Infrared Thermometer DET-3017, Infrared Forehead ThermometerDET-3017a,DET-3017, Infrared Ear/Forehead Thermometer DET-2126,DET-2126b and 45 more | 2017 | 115 |
| Nebulizer (Direct Patient Interface) | Class 2 | 2025 | 42 | |
| Oximeter, Wellness | Class 2 | 11-51D SmartHeart Deluxe Pulse Oximeter, 11-51DA SmartHeart Deluxe Pulse Oximeter, 73-51D Leader Pulse Oximeter | 2024 | 19 |
| Pump, Breast, Non-Powered | Class 1 | 2017 | 33 | |
| Pump, Breast, Powered | Class 2 | Electric Breast Pump(LD-302), Electric Breast Pump, Mya Joy Electric Breast Pump | 2017 | 40 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | ChoiceMMed Blood Pressure Monitor MDBP203, Heart Check Digital Wrist Blood Pressure Monitor, Sensiplast Wrist Blood pressure monitor SBC 39, MEDLOT Electric Blood Pressure Monitor, Volueth Arm-type Fully Automatic Digital Blood Pressure Monitor DBP-62A1B, Arm-type Fully Automatic Digital Blood Pressure Monitor and 68 more | 2017 | 98 |
| Thermometer, Clinical Mercury | Class 2 | 2017 | 12 | |
| Unit, Oral Irrigation | Class 1 | SEJOY Oral Irrigator | 2024 | 128 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Sejoy | DXN | 22 |
| Maynovia | DXN | 13 |
| Bison | FLL | 12 |
| LotFancy | DXN | 10 |
| Medlot | DXN | 6 |
| Maynovia | PGJ | 6 |
| Sejoy | FLL | 4 |
| Rexall | FLL | 3 |
| Sejoy | PGJ | 3 |
| Koios | DXN | 2 |
| Bison | DXN | 2 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 |
| Clinical Electronic Thermometer | SDV | 2 |
| MD | DXN | 1 |
| Veridian | FLL | 1 |
| Lightstuff | DXN | 1 |
| One Step® | FLL | 1 |
| Dreambaby | FLL | 1 |
| Blood Pressure Monitor | DXN | 1 |
| Sovarcate | FLL | 1 |
| caretouch | FLL | 1 |
| Sejoy | EFS | 1 |
| Kroger | FLL | 1 |
| Motif | DXN | 1 |
| Volueth | DXN | 1 |
| careus | FLL | 1 |
| Sejoy Oral Irrigator | EFS | 1 |
| Dorm DOC | FLL | 1 |
| Dorm | FLL | 1 |
| drugmart | FLL | 1 |
| Verature | DXN | 1 |
| WOW | FLL | 1 |
| Nvzzler | HGX | 1 |
Clearances
24 clearances name Joytech Healthcare Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K261394 | 2026-08-26 | DXN | Traditional | This company |
| K253425 | 2026-08-13 | DXN | Traditional | This company |
| K252501 | 2026-04-28 | DXN | Traditional | This company |
| K252685 | 2026-02-13 | DXN | Traditional | This company |
| K243468 | 2025-07-02 | CAF | Traditional | This company |
| K250548 | 2025-06-26 | DXN | Traditional | This company |
| K241431 | 2025-01-13 | DXN | Traditional | This company |
| K241322 | 2024-12-19 | HGX | Traditional | This company |
| K231303 | 2024-01-26 | DXN | Traditional | This company |
| K230566 | 2023-08-25 | DXN | Traditional | This company |
| K213189 | 2022-03-01 | DXN | Traditional | This company |
| K212115 | 2022-01-05 | DXN | Traditional | This company |
| K200649 | 2020-08-03 | DXN | Traditional | This company |
| K200599 | 2020-07-08 | FLL | Traditional | This company |
| K183393 | 2019-11-18 | FLL | Traditional | This company |
| K190886 | 2019-07-29 | DXN | Special | This company |
| K190873 | 2019-07-26 | FLL | Traditional | This company |
| K182629 | 2019-02-28 | FLL | Traditional | This company |
| K181239 | 2018-10-29 | FLL | Traditional | This company |
| K181081 | 2018-10-02 | FLL | Traditional | This company |
| K173024 | 2018-08-22 | DXN | Traditional | This company |
| K172989 | 2017-12-20 | HGX | Traditional | This company |
| K170666 | 2017-11-22 | DXN | Traditional | This company |
| K163518 | 2017-09-19 | FLL | Traditional | This company |
| K112289 | 2011-12-16 | FLL | Traditional | Kang ZE Industrial Co., Ltd. |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.