The following data is part of a premarket notification filed by Neotonus, Inc. with the FDA for Neocontrol Pelvic Floor Therapy System.
Device ID | K001903 |
510k Number | K001903 |
Device Name: | NEOCONTROL PELVIC FLOOR THERAPY SYSTEM |
Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
Applicant | NEOTONUS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
Contact | Sheila Hemeon-heyer |
Correspondent | Sheila Hemeon-heyer NEOTONUS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
Product Code | KPI |
CFR Regulation Number | 876.5320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-06-22 |
Decision Date | 2000-08-29 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
LT2061 | K001903 | 000 |
G680LT2061 | K001903 | 000 |