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FDA 510(k)

TM-300 TRACTION SYSTEM

K-Number: K992545 · 1999-09-01

ApplicantIto Co., Ltd.
Decision Date1999-09-01
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TM-300 TRACTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ito Co., Ltd.. It received FDA 510(k) clearance on 1999-09-01 under 510(k) number K992545. 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 TM-300 TRACTION SYSTEM?

TM-300 TRACTION SYSTEM is a medical device that received FDA 510(k) clearance on 1999-09-01. The listed applicant is Ito Co., Ltd.. The 510(k) number is K992545.

When did TM-300 TRACTION SYSTEM receive FDA 510(k) clearance?

TM-300 TRACTION SYSTEM received FDA 510(k) clearance on 1999-09-01, under 510(k) number K992545.

Who is the listed applicant for TM-300 TRACTION SYSTEM?

The FDA 510(k) record lists Ito Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TM-300 TRACTION SYSTEM?

The FDA product code for TM-300 TRACTION SYSTEM is ITH.

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Other records listing Ito Co., Ltd. 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.

K203525D functionK112520US-101L, US-103SK081943MODEL ES-130K081247TM-400K032793US-100 PORTABLE ULTRASOUND THERAPY UNITK022846SW-180 SHORTWAVE THERAPY 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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