The following data is part of a premarket notification filed by Electro-biology, Inc. with the FDA for Ebi Hand Massaging Pump (hmp).
Device ID | K860632 |
510k Number | K860632 |
Device Name: | EBI HAND MASSAGING PUMP (HMP) |
Classification | Massager, Powered Inflatable Tube |
Applicant | ELECTRO-BIOLOGY, INC. 300 FAIRFIELD RD. Fairfield, NJ 07006 -0293 |
Contact | Anthony C Parkes |
Correspondent | Anthony C Parkes ELECTRO-BIOLOGY, INC. 300 FAIRFIELD RD. Fairfield, NJ 07006 -0293 |
Product Code | IRP |
CFR Regulation Number | 890.5650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-20 |
Decision Date | 1986-04-18 |