EMS2000
by BioMedical Life Systems Inc.
EMS2000 (KEMS) is a medical device (FDA Class II; FDA product code IPF, Stimulator, Muscle, Powered) made by BioMedical Life Systems Inc., cleared under FDA 510(k) K884651 on 6 Nov 1989 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00857771003170), active as of 8 Jun 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00857771003170 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK884651 | Date6 Nov 1989 | StatusActive |
Official records
- AccessGUDID record 00857771003170
- FDA 510(k) database K884651
Across registries
- FDA 510(k) K884651 decided 6 Nov 1989 Active
- FDA GUDID UDI-DI 00857771003170 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K884651
- Listed FDA GUDID 00857771003170
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Model / Ref / Catalog
- EMS2000, KEMS
- Primary DI / UDI-DI
- 00857771003170
- 510(k) Number
- FDA product code
- IPF
- GMDN term
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Device class
- Class II
- Regulation number
- 890.5850
- GUDID distribution status
- In Commercial Distribution
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