LKY · Class II · 21 CFR 876.5020

FDA Product Code LKY: Device, External Penile Rigidity

Intended To Create Or Maintain Sufficient Penile Rigidity For Sexual Intercourse. These Include Vacuum Pumps, Constriction Rings, And Penile Splints, Which Are Mechanical, Powered Or Pneumatic Devices.

Leading manufacturers include Ercons, Inc., Pos-T-Vac, Inc. and Nanma Mfg Co., Ltd..

87
Total
87
Cleared
131d
Avg days
1983
Since

FDA 510(k) Cleared Device, External Penile Rigidity Devices (Product Code LKY)

87 devices
1–24 of 87
Cleared Aug 25, 2004
NANMA VACUUM PUMP PROXZEK MODEL 2M9498S
K041573
Nanma Mfg Co., Ltd.
Gastroenterology & Urology · 72d
Cleared Feb 05, 2002
ERECAID CLASSIC SYSTEM
K020082
Endocare, Inc.
Gastroenterology & Urology · 26d
Cleared Jul 19, 2000
NANMA VACUUM PUMP
K993909
Nanma Mfg Co., Ltd.
Gastroenterology & Urology · 245d
Cleared Jul 10, 2000
SENSATION -VACUUM ASSIST DEVICES
K000124
Prosurg, Inc.
Gastroenterology & Urology · 174d
Cleared Mar 20, 2000
ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS
K993343
Erecxel Enterprises
Gastroenterology & Urology · 167d
Cleared Jan 31, 2000
NANMA NON-ADJUSTABLE CONSTRICTION RING
K993906
Nanma Mfg Co., Ltd.
Gastroenterology & Urology · 75d
Cleared Jan 31, 2000
NANMA AJUSTABLE CONSTRICTION RING
K993908
Nanma Mfg Co., Ltd.
Gastroenterology & Urology · 75d
Cleared Dec 27, 1999
ELITE CUSTOM
K993142
Soma Blue, Inc.
Gastroenterology & Urology · 97d
Cleared Dec 27, 1999
VITALITY SYSTEM
K993143
Soma Blue, Inc.
Gastroenterology & Urology · 97d
Cleared Oct 05, 1999
V.T.S., INC. (V.T.-3)
K992442
Vts, Inc.
Gastroenterology & Urology · 75d
Cleared Feb 24, 1999
ERCO-VAC -C
K990006
Ercons, Inc.
Gastroenterology & Urology · 51d
Cleared Feb 24, 1999
ERCO-RIBBON -C
K990008
Ercons, Inc.
Gastroenterology & Urology · 51d
Cleared Feb 08, 1999
MAX IT
K983438
Dorea, Inc.
Gastroenterology & Urology · 132d
Cleared Dec 04, 1998
RAPPORT V.T.D.
K982275
Owen Mumford USA, Inc.
Gastroenterology & Urology · 158d
Cleared Nov 24, 1998
ERCO-RIBBON
K981343
Ercons, Inc.
Gastroenterology & Urology · 225d
Cleared Nov 24, 1998
ERCO-VAC
K981357
Ercons, Inc.
Gastroenterology & Urology · 224d
Cleared Nov 02, 1998
POS-T-VAC (AVP-1000)
K983245
Pos-T-Vac, Inc.
Gastroenterology & Urology · 47d
Cleared Nov 02, 1998
POS-T-VAC (IVP-600)
K983246
Pos-T-Vac, Inc.
Gastroenterology & Urology · 47d
Cleared Aug 28, 1998
POS-T-VAC (REJOYN VACUUM ERECTION DEVICE)
K981011
Pos-T-Vac, Inc.
Gastroenterology & Urology · 163d
Cleared Aug 28, 1998
REJOYN CONSTRICTION RING KIT, POS-T-VAC B-100 RING KIT, POS-T-VAC B-25 RING KIT AND POS-T-VAC B-10 RING KIT
K981180
Pos-T-Vac, Inc.
Gastroenterology & Urology · 149d
Cleared Jun 25, 1998
VED VALU- VACUUM ERECTION DEVICE
K980948
Mission Pharmacal Comp
Gastroenterology & Urology · 104d
Cleared Jun 25, 1998
RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV)
K981506
Repro-Med Systems, Inc.
Gastroenterology & Urology · 59d
Cleared May 12, 1998
MEGAVAC SYSTEM
K974196
Barry J. Kaplan, Inc.
Gastroenterology & Urology · 186d
Cleared May 06, 1998
CHARGER (ED)
K980567
Walling Medical Equipment Co.
Gastroenterology & Urology · 82d

About Product Code LKY - Regulatory Context