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FDA 510(k)

PORTABLE ISOKINETICS 3003 SHOULDER UNIT

K-Number: K862995 · 1986-08-20

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

Device Summary

PORTABLE ISOKINETICS 3003 SHOULDER 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 K862995. 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 3003 SHOULDER UNIT?

PORTABLE ISOKINETICS 3003 SHOULDER 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 K862995.

When did PORTABLE ISOKINETICS 3003 SHOULDER UNIT receive FDA 510(k) clearance?

PORTABLE ISOKINETICS 3003 SHOULDER UNIT received FDA 510(k) clearance on 1986-08-20, under 510(k) number K862995.

Who is the listed applicant for PORTABLE ISOKINETICS 3003 SHOULDER 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 3003 SHOULDER UNIT?

The FDA product code for PORTABLE ISOKINETICS 3003 SHOULDER 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.

K862993PORTABLE ISOKINETICS 3001 WRIST/ANKLE 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

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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