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FDA 510(k)

BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR

K-Number: K011701 · 2001-06-22

ApplicantTaiwan Armada Enterprise Co., Ltd.
Decision Date2001-06-22
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Armada Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2001-06-22 under 510(k) number K011701. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR?

BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2001-06-22. The listed applicant is Taiwan Armada Enterprise Co., Ltd.. The 510(k) number is K011701.

When did BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR receive FDA 510(k) clearance?

BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR received FDA 510(k) clearance on 2001-06-22, under 510(k) number K011701.

Who is the listed applicant for BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR?

The FDA 510(k) record lists Taiwan Armada Enterprise Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR?

The FDA product code for BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR is IOR.

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.

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Other records listing Taiwan Armada Enterprise 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.

K020188BIOTECH MANUAL WHEELCHAIR, A1000 SUPER SPORT WHEELCHAIRK020472BIOTECH MANUAL WHEELCHAIR B900 SUPER LIGHT WHEELCHAIRK020284BIOTECH MANUAL WHEELCHAIR A2000 SUPER MOTIVE WHEELCHAIRK014198BIOTECH B990K VIVI WHEELCHAIR

Related Devices (Code: IOR)

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.

K253762ErgoSteel (ES0001/696)Strongback Mobility AG C/O Blueaudit GmbHK261919Multifunctional wheelchair (YJ-059)Zhenjiang Assure Medical Equipment Co., Ltd.K260141Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)Zhenjiang Assure Medical Equipment Co., Ltd.K260145YJ-K1K2 Wheelchair (YJ-013F)Zhenjiang Assure Medical Equipment Co., Ltd.K260144Reclining wheelchair (YJ-013L)Zhenjiang Assure Medical Equipment Co., Ltd.K261571Manual Wheelchair (H008, PCK7)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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