Product Code: LGX FDA class 1 21 CFR 878.4960

Table, Examination, Medical, Powered

General, Plastic Surgery

A powered medical examination table is an electrically adjustable table used to position patients during medical examinations and minor procedures, allowing clinicians to change patient positioning with minimal manual effort. The device is FDA Class 1, the lowest risk category, subject to general controls only and not requiring premarket notification. It carries product code LGX and is regulated under 21 CFR 878.4960 within the General, Plastic Surgery specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

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Basic Information

Product Code: LGX
Device Class: FDA class 1
Regulation Number: 878.4960
Medical Specialty: General, Plastic Surgery
Review Panel: HO
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 14 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K945163	ECHOCARDIOGRAPHY	Feb 17, 1995	Substantially Equivalent	Tri W-G, Inc.
K894144	POWER EXAMINATION TABLE MODEL # 405	Aug 28, 1989	Substantially Equivalent	Midmark Corp.
K894134	POWER EXAMINATION TABLE MODEL # 411	Aug 28, 1989	Substantially Equivalent	Midmark Corp.
K883680	MEDALIST EXAMINATION TABLE	Oct 04, 1988	Substantially Equivalent	Hamilton Industries, Inc.
K882010	POWER EXAMINATION TABLE	Jul 13, 1988	Substantially Equivalent	Enochs Mfg., Inc.
K864072	ADEC 1005-C CHAIR	Nov 07, 1986	Substantially Equivalent	Cherne Industries, Inc.
K860519	RELIANCE MODEL 200 PODIATRY CHAIR	Feb 19, 1986	Substantially Equivalent	F. & F. Koenigkramer
K845023	STORZ PLASTIC SURGERY & EXAMINATION LOUNGE 7000	Jan 28, 1985	Substantially Equivalent	Storz Instrument Co.
K830294	MEDICAL EXAM TABLE	Jan 11, 1984	Substantially Equivalent	Coe Laboratories, Inc.
K832768	S & W SW52E W/POWER BACK LIFT	Sep 20, 1983	Substantially Equivalent	S & W Enterprises, Inc.
K820823	MULTIPLE, MODEL #17	Apr 21, 1982	Substantially Equivalent	Midmark Corp.
K811623	SMR PARAGON CHAIR TABLE	Jul 02, 1981	Substantially Equivalent	Smr
K811190	THREE MODELS OF TABLES, STOOLS, & LIGHTS	May 08, 1981	Substantially Equivalent	Midmark Corp.
K810900	CASTLE PROCEDURE AND RITTER EXAM. TABLES	Apr 21, 1981	Substantially Equivalent	Sybron Corp.