HandX
K-Number: K212214 · 2021-09-13
Device Summary
Frequently Asked Questions
What is the HandX?
HandX is a medical device that received FDA 510(k) clearance on 2021-09-13. The listed applicant is Human Xtensions , Ltd.. The 510(k) number is K212214.
When did HandX receive FDA 510(k) clearance?
HandX received FDA 510(k) clearance on 2021-09-13, under 510(k) number K212214.
Who is the listed applicant for HandX?
The FDA 510(k) record lists Human Xtensions , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HandX?
The FDA product code for HandX is GCJ.
Other records listing Human Xtensions , Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: GCJ)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.