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

FDA 510(k)

WELLNESS/JOLIVETE

K-Number: K040905 · 2005-02-23

ApplicantTohkai Precision Ind. , Ltd.
Decision Date2005-02-23
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

WELLNESS/JOLIVETE is the device name listed in this FDA 510(k) record. The listed applicant is Tohkai Precision Ind. , Ltd.. It received FDA 510(k) clearance on 2005-02-23 under 510(k) number K040905. 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 WELLNESS/JOLIVETE?

WELLNESS/JOLIVETE is a medical device that received FDA 510(k) clearance on 2005-02-23. The listed applicant is Tohkai Precision Ind. , Ltd.. The 510(k) number is K040905.

When did WELLNESS/JOLIVETE receive FDA 510(k) clearance?

WELLNESS/JOLIVETE received FDA 510(k) clearance on 2005-02-23, under 510(k) number K040905.

Who is the listed applicant for WELLNESS/JOLIVETE?

The FDA 510(k) record lists Tohkai Precision Ind. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WELLNESS/JOLIVETE?

The FDA product code for WELLNESS/JOLIVETE is IRP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K260944ManaCold Compression SystemManamed, LLCK260529Air Compression Massager (HY-1165)Xiamen High Top Electronic Technology Co., Ltd.K260948Air Compression Massager (EP30B001 I)Wavepulse (Xiamen) Healthcare Technology Co., Ltd.K253919Cryo And Thermo Therapy SystemXiamen Weiyou Intelligent Technology Co., Ltd.K252396Cryo Sport 2.0 (AVA 501)Avanutri Equipamentos DE SaúdeK254200Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14)Wenzhou Lingfeng Electronic Technology Co., Ltd.

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.

↑