Select Neuromuscular Stimulators
510(k) K903434
Select Neuromuscular Stimulators is a Class II device made by Medtronic Vascular, cleared under FDA 510(k) K903434 on 9 Aug 1991, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK903434 | Date9 Aug 1991 | StatusActive |
Official records
- FDA 510(k) database K903434
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GZI
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5810
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
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- COMFORTRON PT (TENS) by M. D. Supply, Inc.
- REHASTIM & REHAMOVE by HASOMED GmbH
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- RT300-S AND RT300-SP FES CYCLE ERGOMETER by Restorative Therapies, Inc.