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FDA 510(k)

ULTRA TRACTION

K-Number: K881603 · 1988-05-04

ApplicantComponent Equipment Mfg., Inc.
Decision Date1988-05-04
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ULTRA TRACTION is the device name listed in this FDA 510(k) record. The listed applicant is Component Equipment Mfg., Inc.. It received FDA 510(k) clearance on 1988-05-04 under 510(k) number K881603. 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 ULTRA TRACTION?

ULTRA TRACTION is a medical device that received FDA 510(k) clearance on 1988-05-04. The listed applicant is Component Equipment Mfg., Inc.. The 510(k) number is K881603.

When did ULTRA TRACTION receive FDA 510(k) clearance?

ULTRA TRACTION received FDA 510(k) clearance on 1988-05-04, under 510(k) number K881603.

Who is the listed applicant for ULTRA TRACTION?

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

What is the FDA product code for ULTRA TRACTION?

The FDA product code for ULTRA TRACTION is ITH.

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Other records listing Component Equipment Mfg., 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.

K901796PODOFLEX EXERCISER-PASSIVE-FOOT/ANKLE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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