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FDA 510(k)

ESCOTEK EST TRAC 401

K-Number: K844385 · 1985-05-01

ApplicantNor-Am Patient Care Products, Inc.
Decision Date1985-05-01
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ESCOTEK EST TRAC 401 is the device name listed in this FDA 510(k) record. The listed applicant is Nor-Am Patient Care Products, Inc.. It received FDA 510(k) clearance on 1985-05-01 under 510(k) number K844385. 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 ESCOTEK EST TRAC 401?

ESCOTEK EST TRAC 401 is a medical device that received FDA 510(k) clearance on 1985-05-01. The listed applicant is Nor-Am Patient Care Products, Inc.. The 510(k) number is K844385.

When did ESCOTEK EST TRAC 401 receive FDA 510(k) clearance?

ESCOTEK EST TRAC 401 received FDA 510(k) clearance on 1985-05-01, under 510(k) number K844385.

Who is the listed applicant for ESCOTEK EST TRAC 401?

The FDA 510(k) record lists Nor-Am Patient Care Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESCOTEK EST TRAC 401?

The FDA product code for ESCOTEK EST TRAC 401 is ITH.

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Other records listing Nor-Am Patient Care Products, 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.

K900647SOUTHERN CROSS HI-V4 PULSED HIGH VOLTAGE GALVANICK844389ESCOTEK EST 210, HIGH VOLTAGE ELECTRO GALVANIC STIK844388ESCOTEK EST 220 INTERFERENCE THERAPY UNITK844387ESCOTEK-EST 221 VACUUM UNITK844390ESCOTEK-EST 204 MULTI STIMK844386ESCOTEK-EST 301A ULTRA-SONIC UNIT

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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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