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)

HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33

K-Number: K071007 · 2007-04-19

ApplicantHeartway Medical Products Co., Ltd.
Decision Date2007-04-19
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33 is the device name listed in this FDA 510(k) record. The listed applicant is Heartway Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2007-04-19 under 510(k) number K071007. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33?

HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33 is a medical device that received FDA 510(k) clearance on 2007-04-19. The listed applicant is Heartway Medical Products Co., Ltd.. The 510(k) number is K071007.

When did HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33 receive FDA 510(k) clearance?

HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33 received FDA 510(k) clearance on 2007-04-19, under 510(k) number K071007.

Who is the listed applicant for HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33?

The FDA 510(k) record lists Heartway Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33?

The FDA product code for HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33 is INI.

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

Other records listing Heartway Medical Products Co., Ltd. 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.

K220227Auto Folding Scooter, S21FK101143HEARTWAY POWER MOBILITY SCOOTER, S11K101142HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34K100327HEARTWAY POWER CHAIR, P23K092650HEARTWAY POWER MOBILITY SCOOTER, S12K092155HEARTWAY POWER MOBILITY SCOOTER, S8

View all 16 devices →

Related Devices (Code: INI)

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.

K261078Electric Scooter (FNS01,FNS03)Anhui Jbh Medical Apparatus Co., Ltd.K261859Electric Scooter (FDB08, FDB08A, FDB12)Anhui JBH Medical Apparatus Co., Ltd.K260094Mobility Scooter (W3465, W3902 (S50 Carbon))Zhejiang Innuovo Rehabilitation Devices Co.,LtdK260176Mobility Scooter (W3483, W3483A)Zhejiang Innuovo Rehabilitation Devices Co.,LtdK261232IERO Mobility Scooter (IERO-01)Jochu Technology Co., Ltd.K261163Mobility Scooter (R200)Yongkang Ruihe Metal Product 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.

↑