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FDA 510(k)

ISOKINETIC SYSTEM, TESTING AND EVALUATION

K-Number: K875235 · 1988-01-19

ApplicantOrthopedic Systems, Inc.
Decision Date1988-01-19
Product CodeIKK
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ISOKINETIC SYSTEM, TESTING AND EVALUATION is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Systems, Inc.. It received FDA 510(k) clearance on 1988-01-19 under 510(k) number K875235. 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 ISOKINETIC SYSTEM, TESTING AND EVALUATION?

ISOKINETIC SYSTEM, TESTING AND EVALUATION is a medical device that received FDA 510(k) clearance on 1988-01-19. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K875235.

When did ISOKINETIC SYSTEM, TESTING AND EVALUATION receive FDA 510(k) clearance?

ISOKINETIC SYSTEM, TESTING AND EVALUATION received FDA 510(k) clearance on 1988-01-19, under 510(k) number K875235.

Who is the listed applicant for ISOKINETIC SYSTEM, TESTING AND EVALUATION?

The FDA 510(k) record lists Orthopedic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISOKINETIC SYSTEM, TESTING AND EVALUATION?

The FDA product code for ISOKINETIC SYSTEM, TESTING AND EVALUATION is IKK.

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Other records listing Orthopedic Systems, 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.

K952495ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEMK920256SPINE MOTION ANALYZER WITH EMGK910736JACKSON MULTIPURPOSE OPERATING TABLEK910031PARK CITY SHOULDER POSITIONERK903938C FIT CUPK892503NUFFIELD TOTAL KNEE

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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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