Rehabilicare, Inc.
New Brighton, MN, US
Rehabilicare, Inc. appears in FDA device records in New Brighton, MN. FDA records list 4 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Rehabilicare, Inc. between 1997 and 2002. The busiest year on record is 1997, with 1. The most recent is 2002, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 1998 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K022405 | MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MIC | GZJ | Substantially Equivalent | |
| K011017 | PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT | GZJ | Substantially Equivalent | |
| K982410 | SMP-PLUS,SX-PLUS,SX MODEL # 49XX SERIES 9 VOLT TENS DEVICE | GZJ | Substantially Equivalent | |
| K971542 | ORTHO DX NEUROMUSCULAR STIMULATOR | IPF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0931-03 | Line Powered RePak, Model Number 1785S | If there was a short, excessive heat could have been generated in the transformer due to the use of the wrong fuse. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain