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FDA 510(k)

C.T.M. MOBILITY SCOOTER MODEL # HS-320

K-Number: K012791 · 2001-10-24

ApplicantWarepalmy Enterprise, LLC (Usa)
Decision Date2001-10-24
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

C.T.M. MOBILITY SCOOTER MODEL # HS-320 is the device name listed in this FDA 510(k) record. The listed applicant is Warepalmy Enterprise, LLC (Usa). It received FDA 510(k) clearance on 2001-10-24 under 510(k) number K012791. 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 C.T.M. MOBILITY SCOOTER MODEL # HS-320?

C.T.M. MOBILITY SCOOTER MODEL # HS-320 is a medical device that received FDA 510(k) clearance on 2001-10-24. The listed applicant is Warepalmy Enterprise, LLC (Usa). The 510(k) number is K012791.

When did C.T.M. MOBILITY SCOOTER MODEL # HS-320 receive FDA 510(k) clearance?

C.T.M. MOBILITY SCOOTER MODEL # HS-320 received FDA 510(k) clearance on 2001-10-24, under 510(k) number K012791.

Who is the listed applicant for C.T.M. MOBILITY SCOOTER MODEL # HS-320?

The FDA 510(k) record lists Warepalmy Enterprise, LLC (Usa) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C.T.M. MOBILITY SCOOTER MODEL # HS-320?

The FDA product code for C.T.M. MOBILITY SCOOTER MODEL # HS-320 is INI.

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Other records listing Warepalmy Enterprise, LLC (Usa) 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.

K012792C.T.M. MOBITIY SCOOTER MODEL #HS-360K002983C.T.M. POWER CHAIR, MODEL HS-5600K000354C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570K000356C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-580K983663C.T.M. MOBILITY SCOOTER, MODEL # HS-666K983662C.T.M. MOBILITY SCOOTER, MODEL # HS-686

View all 7 devices →

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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