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FDA 510(k)

BACK TRAC

K-Number: K781647 · 1978-10-17

ApplicantTech Engineering, Inc.
Decision Date1978-10-17
Product CodeHST
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BACK TRAC is the device name listed in this FDA 510(k) record. The listed applicant is Tech Engineering, Inc.. It received FDA 510(k) clearance on 1978-10-17 under 510(k) number K781647. The device is classified under product code HST. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACK TRAC?

BACK TRAC is a medical device that received FDA 510(k) clearance on 1978-10-17. The listed applicant is Tech Engineering, Inc.. The 510(k) number is K781647.

When did BACK TRAC receive FDA 510(k) clearance?

BACK TRAC received FDA 510(k) clearance on 1978-10-17, under 510(k) number K781647.

Who is the listed applicant for BACK TRAC?

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

What is the FDA product code for BACK TRAC?

The FDA product code for BACK TRAC is HST.

Related Devices (Code: HST)

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.

K162702Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression TableStl International, Inc.K110858LO-BAK TRAXRoland F Berthiaume, DCK984190BACK-ON-TRAC, MODEL 101BOTBack-On-Track, Inc.K872121K AND D HOME TRACTJoseph A. Kott, M.D.K870212ARTHROSCOPIC SHOULDER HOLDERDyonics, Inc.K870125EXTREMITY ELEVATOROrthopedic Systems, Inc.

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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