Product Code: HST FDA class 1 21 CFR 888.5850

Apparatus, Traction, Non-Powered

Orthopedic

A non-powered traction apparatus is an orthopedic device used to apply mechanical traction to the spine or extremities without an electrical power source, employed in the management of musculoskeletal pain, fractures, and degenerative conditions. It is classified as an FDA Class 1 device under 21 CFR 888.5850, indicating low risk and general controls only. Product code HST falls under the Orthopedic medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.

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510(k)s

FEI Numbers

205

Registration Numbers

205

Unique Applicants

Years Active

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Basic Information

Product Code: HST
Device Class: FDA class 1
Regulation Number: 888.5850
Medical Specialty: Orthopedic
Review Panel: NE
Submission Type: 4

Device Characteristics

✓

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 38 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K162702	Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table	Dec 30, 2016	Substantially Equivalent	Stl International, Inc.
K110858	LO-BAK TRAX	Aug 02, 2011	Substantially Equivalent	Roland F Berthiaume, DC
K984190	BACK-ON-TRAC, MODEL 101BOT	Mar 15, 1999	Substantially Equivalent	Back-On-Track, Inc.
K872121	K AND D HOME TRACT	Aug 12, 1987	Substantially Equivalent	Joseph A. Kott, M.D.
K870212	ARTHROSCOPIC SHOULDER HOLDER	Feb 20, 1987	Substantially Equivalent	Dyonics, Inc.
K870125	EXTREMITY ELEVATOR	Feb 04, 1987	Substantially Equivalent	Orthopedic Systems, Inc.
K870102	TUPPER TROLLEY	Feb 03, 1987	Substantially Equivalent	Orthopedic Systems, Inc.
K864765	MODEL 668, TRACTION SPLINT, ADULT	Dec 17, 1986	Substantially Equivalent	Ferno-Washington, Inc.
K862874	THE TOWERED 90/90 UNIT	Aug 07, 1986	Substantially Equivalent	Lossing Orthopedic, Inc.
K860037	SUSPENDER ORTHOPEDIC SUSPENSION DEVICE	Jan 21, 1986	Substantially Equivalent	Comfortex, Inc.
K855179	TRANSFER-TRAX (TM) SPLINT TRACTION	Jan 21, 1986	Substantially Equivalent	Comfortex, Inc.
K844239	NEC-KRADLE BY VENCOR	Nov 19, 1984	Substantially Equivalent	Vencor
K841388	ACUFEX SHOULDER HOLDER	May 16, 1984	Substantially Equivalent	Acufex Microsurgical, Inc.
K841368	HYPERBARIC OXYGEN GURNEY-	May 16, 1984	Substantially Equivalent	Orthopedic Systems, Inc.
K831888	COMPUTERIZED TOMOGRAPHY-HYPERBARIC OXYG	Jul 12, 1983	Substantially Equivalent	Portable Travtion Device Co.
K830244	TRACTION ACCESSORIES	Mar 09, 1983	Substantially Equivalent	Warm & Form, Orthopedic Materials
K823813	TRACTION ACCESSORIES	Jan 14, 1983	Substantially Equivalent	Danek Medical, Inc.
K823395	TRACTION-STEEL FRAMING SYSTEM	Dec 03, 1982	Substantially Equivalent	Orthopedic Systems, Inc.
K823372	OCTAGONAL ALUMINUM FRAMING SYSTEM	Dec 03, 1982	Substantially Equivalent	Orthopedic Systems, Inc.
K823392	FOREARM REDUCTION UNIT	Nov 29, 1982	Substantially Equivalent	Orthopedic Systems, Inc.
K822993	SENATEK	Oct 26, 1982	Substantially Equivalent	American Health Tech., Inc.
K821522	CERVITRAC TRACTION FRAME & CORD	Jun 21, 1982	Substantially Equivalent	George W. Cottrell
K820612	TENSOPLAST SKIN TRACTION KIT	Mar 31, 1982	Substantially Equivalent	Smith & Nephew, Inc.
K813017	NECKTRAC	Nov 25, 1981	Substantially Equivalent	Lossing Orthopedic, Inc.
K813016	ZEE TRACTION SPLINT	Nov 24, 1981	Substantially Equivalent	Zee Medical Products Co., Inc.
K812779	EXTENSIONS-LUSATZTISCH	Oct 26, 1981	Substantially Equivalent	The Telos Co.
K803021	UPPER EXTREMITY TRACTION DEVICE	Dec 12, 1980	Substantially Equivalent	Orthopedic Systems, Inc.
K802555	COTTRELL 90/90 BACKTRAC	Oct 31, 1980	Substantially Equivalent	Lossing Orthopedic, Inc.
K802072	PROT-A-TRAC	Sep 26, 1980	Substantially Equivalent	Robert I. Branick, M.D.
K792248	TAYLOR TRACTION CORD	Nov 30, 1979	Substantially Equivalent	Taylor Medical Equipment
K791919	BAC JAC	Oct 04, 1979	Substantially Equivalent	Haggin Industries, Inc.
K791396	MEDI-TRAK PORTABLE TRACTION DEVICE	Aug 16, 1979	Substantially Equivalent	Medicorp, Inc.
K790729	OCTAGONAL ALUMINUM FRAMING SYSTEM	May 01, 1979	Substantially Equivalent	Orthopedic Systems, Inc.
K771988	VERTETRAC	Feb 01, 1979	Substantially Equivalent	Ballert Orthopedic Corp.
K781647	BACK TRAC	Oct 17, 1978	Substantially Equivalent	Tech Engineering, Inc.
K780233	TRACTION WEIGHT BAGS	Feb 23, 1978	Substantially Equivalent	Biomet, Inc.
K780228	TRACTION UNITS	Feb 23, 1978	Substantially Equivalent	Biomet, Inc.
K770080	BAKER MOBILE TRACTION	Jan 25, 1977	Substantially Equivalent	Orthopedic Equipment Co., Inc.