The following data is part of a premarket notification filed by Biomedical Life Systems, Inc. with the FDA for Pain Buddy.
Device ID | K102051 |
510k Number | K102051 |
Device Name: | PAIN BUDDY |
Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
Applicant | BIOMEDICAL LIFE SYSTEMS, INC. P.O. BOX 1360 Vista, CA 92085 -1360 |
Contact | Gary Bussett |
Correspondent | Gary Bussett BIOMEDICAL LIFE SYSTEMS, INC. P.O. BOX 1360 Vista, CA 92085 -1360 |
Product Code | NUH |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-07-21 |
Decision Date | 2011-07-29 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00857771003101 | K102051 | 000 |
00857771003019 | K102051 | 000 |
10857771003108 | K102051 | 000 |
10857771003016 | K102051 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() PAIN BUDDY 77967260 4292664 Dead/Cancelled |
MEDSERV GROUP, INC. 2010-03-24 |