NormaTec Pulse and NormaTec Pulse Pro
K-Number: K160608 · 2016-04-13
Device Summary
Frequently Asked Questions
What is the NormaTec Pulse and NormaTec Pulse Pro?
NormaTec Pulse and NormaTec Pulse Pro is a medical device that received FDA 510(k) clearance on 2016-04-13. The listed applicant is NormaTec Industries, LP. The 510(k) number is K160608.
When did NormaTec Pulse and NormaTec Pulse Pro receive FDA 510(k) clearance?
NormaTec Pulse and NormaTec Pulse Pro received FDA 510(k) clearance on 2016-04-13, under 510(k) number K160608.
Who is the listed applicant for NormaTec Pulse and NormaTec Pulse Pro?
The FDA 510(k) record lists NormaTec Industries, LP as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NormaTec Pulse and NormaTec Pulse Pro?
The FDA product code for NormaTec Pulse and NormaTec Pulse Pro is IRP.
Other records listing NormaTec Industries, LP 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: IRP)
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.