Jkh USA, LLC
United StatesFDA applicant, unverified
- Devices
- 9
What Jkh USA, LLC makes
JKH USA, LLC manufactures medical devices including pneumatic massage compression boots for circulatory support, disposable face masks for infection control, and transcutaneous electrical nerve stimulation (TENS) devices like the Medi-Direct TENS Pen. Their portfolio also includes a range of blood pressure cuffs for clinical and home use, SpO₂ sensors for pulse oximetry, temperature probes for skin and rectal monitoring, and patient monitoring cables for connectivity. The company produces a stimulator device, the JKH Stimulator Plus, for neuromuscular applications.
These devices are classified as Class II under U.S. regulations and are listed in the FDA’s 510(k) database. The manufacturer operates from the United States, adhering to U.S. medical device compliance requirements.
Catalogue
Massage Compression Boots Ref K201645
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Spo2 Sensor Ref K202851
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Disposable Medical Face Mask Ref K201470
Regimes: 510(k) Registry: 510(k)Medi-Direct TENS Pen Ref K182671
Regimes: 510(k) Registry: 510(k)Patient Monitoring Cables Ref K203635
Regimes: 510(k) Registry: 510(k)JKH Stimulator Plus Ref K182203
Regimes: 510(k) Registry: 510(k)JKH Stimulator Plus Ref K191151
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Jkh USA, LLC have in the registry?
The registry currently lists 9 devices for Jkh USA, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Jkh USA, LLC's devices?
Among its 9 most recently registered devices, Jkh USA, LLC has devices listed in FDA 510(k) (9 devices).
What risk classes do Jkh USA, LLC's devices fall under?
Among its 9 most recently registered devices, the classes recorded for Jkh USA, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Jkh USA, LLC in the registry?
The most recently registered devices listed for Jkh USA, LLC include Massage Compression Boots, Blood Pressure Cuff, U1883S, U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S, U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D, Spo2 Sensor and PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS; Rectum Types: PT2252-AG, PTHP-AG, PTMQ-AG, PTSW-AG, PTSM-15AG, PTSL-AG, PTMR-AG.