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FDA 510(k)

PORTABLE ISOKINETICS 3001 WRIST/ANKLE UNIT

K-Number: K862993 · 1986-08-20

ApplicantKent Design & Manufacturing, Inc.
Decision Date1986-08-20
Product CodeIKK
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PORTABLE ISOKINETICS 3001 WRIST/ANKLE UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Kent Design & Manufacturing, Inc.. It received FDA 510(k) clearance on 1986-08-20 under 510(k) number K862993. The device is classified under product code IKK. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTABLE ISOKINETICS 3001 WRIST/ANKLE UNIT?

PORTABLE ISOKINETICS 3001 WRIST/ANKLE UNIT is a medical device that received FDA 510(k) clearance on 1986-08-20. The listed applicant is Kent Design & Manufacturing, Inc.. The 510(k) number is K862993.

When did PORTABLE ISOKINETICS 3001 WRIST/ANKLE UNIT receive FDA 510(k) clearance?

PORTABLE ISOKINETICS 3001 WRIST/ANKLE UNIT received FDA 510(k) clearance on 1986-08-20, under 510(k) number K862993.

Who is the listed applicant for PORTABLE ISOKINETICS 3001 WRIST/ANKLE UNIT?

The FDA 510(k) record lists Kent Design & Manufacturing, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORTABLE ISOKINETICS 3001 WRIST/ANKLE UNIT?

The FDA product code for PORTABLE ISOKINETICS 3001 WRIST/ANKLE UNIT is IKK.

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 Kent Design & Manufacturing, 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.

K862995PORTABLE ISOKINETICS 3003 SHOULDER UNITK862998PORTABLE ISOKINETICS 3007 BACK/ABDOMEN UNITK862994PORTABLE ISOKINETICS 3002 ISO KANE IIK862996PORTABLE ISOKINETICS 3004 KNEE UNITK862997PORTABLE ISOKINETICS 3005 HIP UNIT

Related Devices (Code: IKK)

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.

K123746AMES THERAPY DEVICEAmes Technology, Inc.K952090HUMAC SYSTEMComputer Sports Medicine, Inc.K951770BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3APBiodex Medical Systems, Inc.K951916CC RIDER, MODEL ME180Mettler Electronics Corp.K950095CYBEX 770CybexK942229MOTIVATOR FTR 2000Hogan & Hartson

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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