Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Massage Compression Boots

K-Number: K201645 · 2020-09-15

ApplicantJkh USA, LLC
Decision Date2020-09-15
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Massage Compression Boots is a medical device manufactured by Jkh USA, LLC. It received FDA 510(k) clearance on 2020-09-15 under approval number K201645. 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 Massage Compression Boots?

Massage Compression Boots is a medical device that received FDA 510(k) clearance on 2020-09-15. It is manufactured by Jkh USA, LLC. The 510(k) number is K201645.

When was Massage Compression Boots approved by the FDA?

Massage Compression Boots received FDA 510(k) clearance on 2020-09-15, under approval number K201645.

What company makes Massage Compression Boots?

Massage Compression Boots is manufactured by Jkh USA, LLC.

What is the FDA product code for Massage Compression Boots?

The FDA product code for Massage Compression Boots is IRP.

Related Clinical Trials

NCT07573189 The Effects of Recovery Compression Boots on Blood Lactate Levels, Functional Movement, and Joint Ange of Motion in Collegiate Athletes. ACTIVE_NOT_RECRUITING NCT06911385 Augmenting Cerebral Blood Flow in Acute Ischemic Stroke NOT_YET_RECRUITING NCT06815367 Pneumatic Compression vs Blood Flow Restriction for Muscle Recovery RECRUITING

Other Devices by Jkh USA, LLC

K182671Medi-Direct TENS Pen K191151JKH Stimulator Plus K182203JKH Stimulator Plus K202851Spo2 Sensor K201470Disposable Medical Face Mask K203636PlusCare 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

View all 9 devices →

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.

↑