Rehabilicare, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Rehabilicare, Inc. makes
Rehabilicare, Inc. manufactures transcutaneous electrical nerve stimulation (TENS) devices and neuromuscular stimulators, including models like the PROMAX-XP, PROMAX-TENS, PROMAX-LIBRA, and PROMAX-MC, which combine TENS and microcurrent therapies. Additional offerings include the SMP-PLUS and SX-PLUS series (9V TENS units) and the ORTHO DX neuromuscular stimulator, designed for pain management and muscle stimulation.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company’s products are listed in the FDA’s 510(k) database, reflecting their authorised status for commercial distribution in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Ortho Dx Neuromuscular Stimulator Ref K971542
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Rehabilicare, Inc., initiated on 2003-05-23. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2003
- 23 May 2003 Z-0931-03 Unclassified (pre-2012) Terminated If there was a short, excessive heat could have been generated in the transformer due to the use of the wrong fuse.
Frequently asked questions
How many devices does Rehabilicare, Inc. have in the registry?
The registry currently lists 4 devices for Rehabilicare, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rehabilicare, Inc.'s devices?
Among its 4 most recently registered devices, Rehabilicare, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Rehabilicare, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Rehabilicare, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Rehabilicare, Inc.?
FDA recall records list 1 recall initiated by Rehabilicare, Inc., the most recent initiated on 23 May 2003. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Rehabilicare, Inc. in the registry?
The most recently registered devices listed for Rehabilicare, Inc. include MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MIC, PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT, SMP-PLUS, SX-PLUS, SX MODEL # 49XX SERIES 9 VOLT TENS DEVICE and ORTHO DX NEUROMUSCULAR STIMULATOR.