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FDA 510(k)

TEC VARI-TRAC II TRACTION UNIT

K-Number: K862846 · 1986-08-07

ApplicantTherapeutic Equipment Corp.
Decision Date1986-08-07
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TEC VARI-TRAC II TRACTION UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Therapeutic Equipment Corp.. It received FDA 510(k) clearance on 1986-08-07 under 510(k) number K862846. 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 TEC VARI-TRAC II TRACTION UNIT?

TEC VARI-TRAC II TRACTION UNIT is a medical device that received FDA 510(k) clearance on 1986-08-07. The listed applicant is Therapeutic Equipment Corp.. The 510(k) number is K862846.

When did TEC VARI-TRAC II TRACTION UNIT receive FDA 510(k) clearance?

TEC VARI-TRAC II TRACTION UNIT received FDA 510(k) clearance on 1986-08-07, under 510(k) number K862846.

Who is the listed applicant for TEC VARI-TRAC II TRACTION UNIT?

The FDA 510(k) record lists Therapeutic Equipment Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEC VARI-TRAC II TRACTION UNIT?

The FDA product code for TEC VARI-TRAC II TRACTION UNIT is ITH.

Related Clinical Trials

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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Other records listing Therapeutic Equipment Corp. 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.

K852065PRESTON LOWER LIMB CPM UNITK843637HEALTH PULSE FA-222 TRANSCUTANEOUS ELEC. NERVE STIK843638HEALTH PULSE FA-222 POWER MUSCLE STIMUL

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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