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FDA 510(k)

PHYSICAL MEDICINE & REHABILITATION EQUIP

K-Number: K822906 · 1982-10-15

ApplicantI-Rep, Inc.
Decision Date1982-10-15
Product CodeION
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PHYSICAL MEDICINE & REHABILITATION EQUIP is the device name listed in this FDA 510(k) record. The listed applicant is I-Rep, Inc.. It received FDA 510(k) clearance on 1982-10-15 under 510(k) number K822906. The device is classified under product code ION. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHYSICAL MEDICINE & REHABILITATION EQUIP?

PHYSICAL MEDICINE & REHABILITATION EQUIP is a medical device that received FDA 510(k) clearance on 1982-10-15. The listed applicant is I-Rep, Inc.. The 510(k) number is K822906.

When did PHYSICAL MEDICINE & REHABILITATION EQUIP receive FDA 510(k) clearance?

PHYSICAL MEDICINE & REHABILITATION EQUIP received FDA 510(k) clearance on 1982-10-15, under 510(k) number K822906.

Who is the listed applicant for PHYSICAL MEDICINE & REHABILITATION EQUIP?

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

What is the FDA product code for PHYSICAL MEDICINE & REHABILITATION EQUIP?

The FDA product code for PHYSICAL MEDICINE & REHABILITATION EQUIP is ION.

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Other records listing I-Rep, 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.

K930692LATHAM TABLEK930691ACCUTRAC TRACTION UNITK861864MEDTRON TYPE P-300 ULTRASONIC THERAPY UNITK854947REHABILITATION TABLESK851690ADJUSTABLE TREATMENT TABLESK842268VACUPULSE VACUUM UNIT

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Related Devices (Code: ION)

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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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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