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510(k) K981506

RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV) by Repro-Med Systems, Inc. — Product Code LKY

K981506 is an FDA 510(k) premarket notification submitted by Repro-Med Systems, Inc. for the device "RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV)". The FDA issued a decision of Substantially Equivalent on June 25, 1998. The device falls under product code LKY (Device, External Penile Rigidity), a Class II device regulated under 21 CFR 876.5020. Repro-Med Systems, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1998
Date Received
April 27, 1998
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 Repro-Med Systems, Inc.

  • K102512 — RMS SUBCUTANEOUS NEEDLE SET (May 20, 2011)
  • K933652 — FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING (May 18, 1994)
  • K894299 — REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM (September 22, 1989)
  • K892529 — REPRO-MED NEONATE ASPIRATION SYSTEM (June 12, 1989)
  • K844401 — REPRO-MED SYSTEMS INFUSION DEVICE (March 12, 1985)

Other clearances for product code LKY

  • K041573 — NANMA VACUUM PUMP PROXZEK MODEL 2M9498S (August 25, 2004)
  • 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)
  • K020154 — VT-1 (April 4, 2002)
  • K020258 — SUPPORT SLEEVE (April 4, 2002)

FDA data resources