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FDA 510(k)

PRIMECHAIR

K-Number: K021199 · 2002-07-12

ApplicantDalton Medical Corp.
Decision Date2002-07-12
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PRIMECHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Dalton Medical Corp.. It received FDA 510(k) clearance on 2002-07-12 under 510(k) number K021199. 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 PRIMECHAIR?

PRIMECHAIR is a medical device that received FDA 510(k) clearance on 2002-07-12. The listed applicant is Dalton Medical Corp.. The 510(k) number is K021199.

When did PRIMECHAIR receive FDA 510(k) clearance?

PRIMECHAIR received FDA 510(k) clearance on 2002-07-12, under 510(k) number K021199.

Who is the listed applicant for PRIMECHAIR?

The FDA 510(k) record lists Dalton Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRIMECHAIR?

The FDA product code for PRIMECHAIR is ITI.

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Other records listing Dalton Medical Corp. 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.

K080373TACAHE PC1350 POWER WHEELCHAIRK071282MODEL SEGAEGO 4D SCOOTERK071284MODEL SEGAEGO 3D SCOOTERK052534TACAHEK052496PRIMECHAIRK010395E-POWER

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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.

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