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FDA 510(k)

SUSPENDER ORTHOPEDIC SUSPENSION DEVICE

K-Number: K860037 · 1986-01-21

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

Device Summary

SUSPENDER ORTHOPEDIC SUSPENSION DEVICE 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 K860037. 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 SUSPENDER ORTHOPEDIC SUSPENSION DEVICE?

SUSPENDER ORTHOPEDIC SUSPENSION DEVICE 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 K860037.

When did SUSPENDER ORTHOPEDIC SUSPENSION DEVICE receive FDA 510(k) clearance?

SUSPENDER ORTHOPEDIC SUSPENSION DEVICE received FDA 510(k) clearance on 1986-01-21, under 510(k) number K860037.

Who is the listed applicant for SUSPENDER ORTHOPEDIC SUSPENSION DEVICE?

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 SUSPENDER ORTHOPEDIC SUSPENSION DEVICE?

The FDA product code for SUSPENDER ORTHOPEDIC SUSPENSION DEVICE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K855179TRANSFER-TRAX (TM) SPLINT TRACTIONK855181COMFORTEX 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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