Approval for addition of a 3x5-inch package insert (to be used as a daily patient reminder of the key elements of orthopak unit maintenance) into the case of every shipped orthopak(r) unit. Each card contains the following information: bioelectron, inc. , 800-524-0677 call this number for batteries, electrodes, questions or billing inquiries. 1) change battery every morning. 2) change electrodes every 3-7 days or when they will not stick to your skin. Make sure yoru skin is clean and dry before applying new electrodes.
| Device | ORTHOPAK BONE GROWTH STIMULATOR |
| Classification Name | Stimulator, Bone Growth, Non-invasive |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | EBI, LLC |
| Date Received | 1999-07-09 |
| Decision Date | 1999-07-26 |
| PMA | P850022 |
| Supplement | S012 |
| Product Code | LOF |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EBI, LLC 399 Jefferson Road parsippany, NJ 07054 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P850022 | | Original Filing |
| S031 |
2022-10-28 |
30-day Notice |
| S030 |
2019-09-10 |
Real-time Process |
| S029 |
2018-03-01 |
30-day Notice |
| S028 |
2016-11-08 |
30-day Notice |
| S027 |
2015-12-17 |
30-day Notice |
| S026 |
2015-10-08 |
30-day Notice |
| S025 |
2015-08-10 |
30-day Notice |
| S024 |
2015-04-24 |
Real-time Process |
| S023 |
2014-08-04 |
30-day Notice |
| S022 |
2014-04-10 |
30-day Notice |
| S021 |
2014-02-24 |
30-day Notice |
| S020 |
2013-08-13 |
Special (immediate Track) |
| S019 | | |
| S018 |
2011-06-13 |
Real-time Process |
| S017 |
2009-09-16 |
Normal 180 Day Track |
| S016 |
2006-02-06 |
Normal 180 Day Track |
| S015 |
2003-09-30 |
Normal 180 Day Track |
| S014 |
2003-04-23 |
Special (immediate Track) |
| S013 |
2001-06-11 |
Normal 180 Day Track |
| S012 |
1999-07-09 |
Real-time Process |
| S011 |
1998-06-18 |
Real-time Process |
| S010 | | |
| S009 |
1997-03-13 |
Panel Track |
| S008 |
1992-10-05 |
Normal 180 Day Track |
| S007 |
1992-09-24 |
Normal 180 Day Track |
| S006 |
1989-08-25 |
Normal 180 Day Track |
| S005 |
1989-01-26 |
Normal 180 Day Track |
| S004 |
1987-08-04 |
Normal 180 Day Track |
| S003 |
1986-11-17 |
Special (immediate Track) |
| S002 | | |
| S001 |
1986-09-16 |
Special (immediate Track) |
NIH GUDID Devices