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FDA 510(k)

POWER SCOOTER, MODEL TL0821

K-Number: K042011 · 2004-09-24

ApplicantTeh Lin Prosthetic & Orthopaedic, Inc.
Decision Date2004-09-24
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

POWER SCOOTER, MODEL TL0821 is the device name listed in this FDA 510(k) record. The listed applicant is Teh Lin Prosthetic & Orthopaedic, Inc.. It received FDA 510(k) clearance on 2004-09-24 under 510(k) number K042011. 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 POWER SCOOTER, MODEL TL0821?

POWER SCOOTER, MODEL TL0821 is a medical device that received FDA 510(k) clearance on 2004-09-24. The listed applicant is Teh Lin Prosthetic & Orthopaedic, Inc.. The 510(k) number is K042011.

When did POWER SCOOTER, MODEL TL0821 receive FDA 510(k) clearance?

POWER SCOOTER, MODEL TL0821 received FDA 510(k) clearance on 2004-09-24, under 510(k) number K042011.

Who is the listed applicant for POWER SCOOTER, MODEL TL0821?

The FDA 510(k) record lists Teh Lin Prosthetic & Orthopaedic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWER SCOOTER, MODEL TL0821?

The FDA product code for POWER SCOOTER, MODEL TL0821 is INI.

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Other records listing Teh Lin Prosthetic & Orthopaedic, 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.

K051116MODEL TL-560 POWER SCOOTERK051118MODEL TL-360 POWER SCOOTERK042012TEH LIN POWER SCOOTER, MODEL TL-822K042010POWER SCOOTER, MODEL TL-688K041752TEH LIN POWERED WHEELCHAIR, MDG-601K022696TEH LIN POWERED WHEELCHAIR, MODEL MDG-201

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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.

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