Normatec 3
K-Number: K220217 · 2022-02-25
ApplicantNormaTec Industries, LP
Decision Date2022-02-25
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Normatec 3 is a medical device manufactured by NormaTec Industries, LP. It received FDA 510(k) clearance on 2022-02-25 under approval number K220217. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Normatec 3?
Normatec 3 is a medical device that received FDA 510(k) clearance on 2022-02-25. It is manufactured by NormaTec Industries, LP. The 510(k) number is K220217.
When was Normatec 3 approved by the FDA?
Normatec 3 received FDA 510(k) clearance on 2022-02-25, under approval number K220217.
What company makes Normatec 3?
Normatec 3 is manufactured by NormaTec Industries, LP.
What is the FDA product code for Normatec 3?
The FDA product code for Normatec 3 is IRP.
Other Devices by NormaTec Industries, LP
Related Devices (Code: IRP)
K160608NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP
K171685Med4 EliteCool Systems, Inc. (Dba Game Ready)
K161907Pressure Therapy SystemXiamen Senyang Co., Ltd.
K163280RP Lite 760RMego Afek AC , Ltd.
K160178Lympha-Flow(LF1200)Daesung Maref Co., Ltd.
K183169Pulse 2.0, Pulse Pro 2.0NormaTec Industries, LP
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.