510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Joytech Healthcare Co., Ltd.

Hangzhou Zhejiang, CN

JOYTECH HEALTHCARE CO., LTD. appears in FDA device records in Hangzhou Zhejiang, CN. FDA records list 23 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
23
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 23 510(k) clearances for Joytech Healthcare Co., Ltd. between 2017 and 2026. The busiest year on record is 2019, with 4. The most recent is 2026, with 3.

Clearances by year, as a table
510(k) clearance decisions for Joytech Healthcare Co., Ltd., by decision year
YearClearances
20173
20183
20194
20202
20222
20231
20242
20253
20263
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)DXNSubstantially Equivalent
K252501Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L)DXNSubstantially Equivalent
K252685Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)DXNSubstantially Equivalent
K243468Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)CAFSubstantially Equivalent
K250548Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)DXNSubstantially Equivalent
K241431Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193)DXNSubstantially Equivalent
K241322Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)HGXSubstantially Equivalent
K231303Arm-type Fully Automatic Digital Blood Pressure MonitorDXNSubstantially Equivalent
K230566Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure MonitorDXNSubstantially Equivalent
K213189Wrist-type Fully Automatic Digital Blood Pressure MonitorDXNSubstantially Equivalent
K212115Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure MonitorDXNSubstantially Equivalent
K200649Arm-Type Fully Automatic Digital Blood Pressure MonitorDXNSubstantially Equivalent
K200599Digital ThermometerFLLSubstantially Equivalent
K183393Digital ThermometerFLLSubstantially Equivalent
K190886Non-invasive blood pressure measurement systemsDXNSubstantially Equivalent
K190873Infrared Ear/Forehead ThermometerFLLSubstantially Equivalent
K182629Digital ThermometerFLLSubstantially Equivalent
K181239Infrared Forehead Thermometer, Infrared Ear/Forehead ThermometerFLLSubstantially Equivalent
K181081Infrared Ear ThermometerFLLSubstantially Equivalent
K173024Non-invasive blood pressure measurement systemsDXNSubstantially Equivalent
K172989Electric Breast PumpHGXSubstantially Equivalent
K170666The Wrist-Type Fully Automatic Digital Blood Pressure MonitorsDXNSubstantially Equivalent
K163518Digital ThermometerFLLSubstantially Equivalent

Registered establishments

FDA registered establishments for Joytech Healthcare Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30306716083030671608JOYTECH HEALTHCARE CO., LTD.No.502, Shunda Road, Hangzhou Zhejiang 311100 CN2026
30130530583013053058JOYTECH HEALTHCARE CO.,LTD.No.365, Wuzhou Road, Hangzhou Zhejiang 311100 CN2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Joytech Healthcare Co., Ltd. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain