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FDA 510(k)

ACCUTRAC TRACTION UNIT

K-Number: K930691 · 1993-07-22

ApplicantI-Rep, Inc.
Decision Date1993-07-22
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ACCUTRAC TRACTION UNIT 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 1993-07-22 under 510(k) number K930691. The device is classified under product code ITH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUTRAC TRACTION UNIT?

ACCUTRAC TRACTION UNIT is a medical device that received FDA 510(k) clearance on 1993-07-22. The listed applicant is I-Rep, Inc.. The 510(k) number is K930691.

When did ACCUTRAC TRACTION UNIT receive FDA 510(k) clearance?

ACCUTRAC TRACTION UNIT received FDA 510(k) clearance on 1993-07-22, under 510(k) number K930691.

Who is the listed applicant for ACCUTRAC TRACTION UNIT?

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 ACCUTRAC TRACTION UNIT?

The FDA product code for ACCUTRAC TRACTION UNIT is ITH.

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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 TABLEK861864MEDTRON TYPE P-300 ULTRASONIC THERAPY UNITK854947REHABILITATION TABLESK851690ADJUSTABLE TREATMENT TABLESK842268VACUPULSE VACUUM UNITK832940ROTAGYM

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Related Devices (Code: ITH)

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.

K243775True Non-Surgical Spinal Decompression System (DRX9000-SL)Excite Medical of Tampa Bay, LLCK243366DRX9000C-SL Cervical Spinal Decompression SystemExcite Medical of Tampa Bay, LLCK214037Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracErgo-Flex Technologies, LLCK222912c1TracZimmer Medizinsysteme GmbHK112074EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800Everyway Medical Instruments Co.,LtdK103248INTEGRITY SPINAL CARE SYSTEMIntegra Life Sciences

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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