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)

BIOTECH POWERED WHEELCHAIR, C650PW

K-Number: K011846 · 2002-01-18

Decision Date2002-01-18
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BIOTECH POWERED WHEELCHAIR, C650PW is the device name listed in this FDA 510(k) record. The listed applicant is Roc Chinese-European Industrial Research Society. It received FDA 510(k) clearance on 2002-01-18 under 510(k) number K011846. 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 BIOTECH POWERED WHEELCHAIR, C650PW?

BIOTECH POWERED WHEELCHAIR, C650PW is a medical device that received FDA 510(k) clearance on 2002-01-18. The listed applicant is Roc Chinese-European Industrial Research Society. The 510(k) number is K011846.

When did BIOTECH POWERED WHEELCHAIR, C650PW receive FDA 510(k) clearance?

BIOTECH POWERED WHEELCHAIR, C650PW received FDA 510(k) clearance on 2002-01-18, under 510(k) number K011846.

Who is the listed applicant for BIOTECH POWERED WHEELCHAIR, C650PW?

The FDA 510(k) record lists Roc Chinese-European Industrial Research Society as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOTECH POWERED WHEELCHAIR, C650PW?

The FDA product code for BIOTECH POWERED WHEELCHAIR, C650PW 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.

Other records listing Roc Chinese-European Industrial Research Society 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.

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.

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.

↑