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FDA 510(k)

TRANSFER-TRAX (TM) SPLINT TRACTION

K-Number: K855179 · 1986-01-21

ApplicantComfortex, Inc.
Decision Date1986-01-21
Product CodeHST
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRANSFER-TRAX (TM) SPLINT TRACTION is the device name listed in this FDA 510(k) record. The listed applicant is Comfortex, Inc.. It received FDA 510(k) clearance on 1986-01-21 under 510(k) number K855179. 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 TRANSFER-TRAX (TM) SPLINT TRACTION?

TRANSFER-TRAX (TM) SPLINT TRACTION is a medical device that received FDA 510(k) clearance on 1986-01-21. The listed applicant is Comfortex, Inc.. The 510(k) number is K855179.

When did TRANSFER-TRAX (TM) SPLINT TRACTION receive FDA 510(k) clearance?

TRANSFER-TRAX (TM) SPLINT TRACTION received FDA 510(k) clearance on 1986-01-21, under 510(k) number K855179.

Who is the listed applicant for TRANSFER-TRAX (TM) SPLINT TRACTION?

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

What is the FDA product code for TRANSFER-TRAX (TM) SPLINT TRACTION?

The FDA product code for TRANSFER-TRAX (TM) SPLINT TRACTION is HST.

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 Comfortex, 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.

K860037SUSPENDER ORTHOPEDIC SUSPENSION DEVICEK855181COMFORTEX WHEELCHAIR CUSHIONK854270MURPHY ADJUSTABLE SPLINT

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

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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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