SunMed 8-1053-63
by SunMed
SunMed 8-1053-63 is a medical device (FDA Class II; FDA product code BXN, Stimulator, Nerve, Battery-Powered) made by SunMed, cleared under FDA 510(k) K153045 on 13 May 2016 and listed in FDA GUDID since 1 Aug 2023 (UDI-DI 10889483171127), active as of 23 Oct 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 | Number10889483171127 | Date1 Aug 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK153045 | Date13 May 2016 | StatusActive |
Official records
- AccessGUDID record 10889483171127
- FDA 510(k) database K153045
Across registries
- FDA 510(k) K153045 decided 13 May 2016 Active
- FDA GUDID UDI-DI 10889483171127 listed 1 Aug 2023 Listed
Timeline
- Cleared FDA 510(k) K153045
- Listed FDA GUDID 10889483171127
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SunMed
- Generic name
- Block-monitoring peripheral nerve electrical stimulation system
- Model / Ref / Catalog
- 8-1053-63
- Primary DI / UDI-DI
- 10889483171127
- 510(k) Number
- FDA product code
- BXN
- GMDN term
- Block-monitoring peripheral nerve electrical stimulation system
- Device class
- Class II
- Regulation number
- 868.2775
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code BXN (STIMULATOR, NERVE, BATTERY-POWERED).
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- MODEL NS242 CONSTANT CURRENT PERIPHERAL NERVE STIM by Fisher & Paykel Electronics, Ltd.
- MS-III MINISTIM by Life-Tech Intl., Inc.
- THE GRIPPER by Regional Master Corp.
- Stimuplex HNS-12, Model 4892098 by Stockert GmbH
- MODIFIED AXOSTIM by Singer Medical Products, Inc.
- MYOTEST NERVE STIMULATOR by Prothia USA, Inc.
- StimPod NMS450 Nerve Stimulator by XAVANT TECHNOLOGY (PTY) LTD
- MEDAR APM FORCE TRANSDUCER by Medar Corp., Inc.