510(k) K041573

NANMA VACUUM PUMP PROXZEK MODEL 2M9498S by Nanma Mfg Co., Ltd. — Product Code LKY

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 25, 2004
Date Received: June 14, 2004
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Device, External Penile Rigidity
Device Class: Class II
Regulation Number: 876.5020
Review Panel: GU
Submission Type

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.

Other clearances by Nanma Mfg Co., Ltd.

K030119 — NANMA ADJUSTABLE CONSTRICTION RING (August 6, 2003)
K030913 — NANMA VACUUM PUMP (June 3, 2003)
K013113 — MODIFICATION TO NANMA VACUUM PUMP (December 20, 2002)
K013051 — NANMA ADJUSTABLE CONSTRICTION RING (August 22, 2002)
K013053 — MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING (May 9, 2002)
K993909 — NANMA VACUUM PUMP (July 19, 2000)
K993908 — NANMA AJUSTABLE CONSTRICTION RING (January 31, 2000)
K993906 — NANMA NON-ADJUSTABLE CONSTRICTION RING (January 31, 2000)

Other clearances for product code LKY

K032776 — VACURECT VACUUM CONSTRICTION DEVICE (October 3, 2003)
K030119 — NANMA ADJUSTABLE CONSTRICTION RING (August 6, 2003)
K030913 — NANMA VACUUM PUMP (June 3, 2003)
K013113 — MODIFICATION TO NANMA VACUUM PUMP (December 20, 2002)
K013051 — NANMA ADJUSTABLE CONSTRICTION RING (August 22, 2002)
K020969 — VACURECT VACUUM CONSTRICTION DEVICE (June 5, 2002)
K013053 — MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING (May 9, 2002)
K020258 — SUPPORT SLEEVE (April 4, 2002)
K020154 — VT-1 (April 4, 2002)
K020082 — ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYS (February 5, 2002)