Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)
K-Number: K251623 · 2025-09-17
Decision Date2025-09-17
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) is a medical device manufactured by Shenzhen Yicai Health Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-17 under approval number K251623. 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 Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)?
Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) is a medical device that received FDA 510(k) clearance on 2025-09-17. It is manufactured by Shenzhen Yicai Health Technology Co., Ltd.. The 510(k) number is K251623.
When was Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) approved by the FDA?
Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) received FDA 510(k) clearance on 2025-09-17, under approval number K251623.
What company makes Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)?
Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) is manufactured by Shenzhen Yicai Health Technology Co., Ltd..
What is the FDA product code for Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)?
The FDA product code for Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) is IRP.
Related Clinical Trials
NCT07613931
Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment
NOT_YET_RECRUITING
NCT07372677
Pocket-X Gel Non-surgical Periodontal Therapy
RECRUITING
NCT07614373
Virtual Reality-based Mindfulness Training for Mental Health After Stroke
NOT_YET_RECRUITING
NCT07614568
Evaluating the Efficacy and Safety of Octane Aether for Treating Chronic Low Back Pain
NOT_YET_RECRUITING
NCT07615569
Robot-assisted Versus Conventional Physical Therapy for Hand in Sub-acute Stroke
RECRUITING
NCT07611721
Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy.
RECRUITING
Related PubMed Literature
PMID: 41072144
Use of Bayesian decision analysis in the design of patient-centered clinical trials for kidney failure devices.
Computers in biology and medicine (2025)
PMID: 41040861
Enhancing post-operative hypothyroidism treatment: rat thyroid autotransplantation into a pre-vascularized, retrievable cell pouch™ device.
Frontiers in endocrinology (2025)
PMID: 40290478
Mental health apps in India: regulatory landscape and future directions.
BJPsych international (2025)
Other Devices by Shenzhen Yicai Health Technology Co., Ltd.
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.