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)

KARMA-RS, KARMA-FS WHEELCHAIRS

K-Number: K884812 · 1988-12-27

ApplicantOrthofab, Inc.
Decision Date1988-12-27
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

KARMA-RS, KARMA-FS WHEELCHAIRS is the device name listed in this FDA 510(k) record. The listed applicant is Orthofab, Inc.. It received FDA 510(k) clearance on 1988-12-27 under 510(k) number K884812. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARMA-RS, KARMA-FS WHEELCHAIRS?

KARMA-RS, KARMA-FS WHEELCHAIRS is a medical device that received FDA 510(k) clearance on 1988-12-27. The listed applicant is Orthofab, Inc.. The 510(k) number is K884812.

When did KARMA-RS, KARMA-FS WHEELCHAIRS receive FDA 510(k) clearance?

KARMA-RS, KARMA-FS WHEELCHAIRS received FDA 510(k) clearance on 1988-12-27, under 510(k) number K884812.

Who is the listed applicant for KARMA-RS, KARMA-FS WHEELCHAIRS?

The FDA 510(k) record lists Orthofab, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KARMA-RS, KARMA-FS WHEELCHAIRS?

The FDA product code for KARMA-RS, KARMA-FS WHEELCHAIRS is ITI.

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 Orthofab, Inc. 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.

K962565POWERED WHEELCHAIRK952675ORTHOFAB WHEELCHAIRK950904ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR)K950903ORTHOFAB WHEELCHAIR ULTIMA (RIGID FRAME MANUAL WHEELCHAIR)K860095DIGIKIT NONPNEUMATIC TOURNIQUETK852661APOLLO STERILE BLADES

View all 7 devices →

Related Devices (Code: ITI)

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.

K262582Electric wheelchair (GP100)Suzhou Green Pine Medical Co., Ltd.K262054Electric WheelchairYongkang Joymax Medical Technology Co., Ltd.K260053Power Wheelchair (OS-R-M01I)Beijing OrionStar Technology Co., Ltd.K260229Electric wheelchair (HC819N, HC830N, HC831N)Yongkang Hengyi Vehicle Co., Ltd.K261354Electric wheelchair (D03)Foshan Sowell Medical Technology Co., Ltd.K261149Electric Wheelchair (DY611A-2, DY612A-1)Zhejiang Lumbre Electric Appliance 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.

↑