Stand-alone mode Kit SPM01K1
by Ncs Lab SRL
Stand-alone mode Kit SPM01K1 is a Class II device made by Ncs Lab SRL, listed in FDA GUDID since 1 Sep 2021 (UDI-DI 08051122040940), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08051122040940 | Date1 Sep 2021 | StatusListed |
Official records
- AccessGUDID record 08051122040940
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Stand-alone mode Kit
- Generic name
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Model / Ref / Catalog
- SPM01K1
- Primary DI / UDI-DI
- 08051122040940
- FDA product code
- IPF, KQX, HCC
- GMDN term
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Device class
- Class II
- Regulation number
- 890.5850, 888.1500, 882.5050
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code IPF (Stimulator, Muscle, Powered).
- RS-4M by Rs Medical
- RICH-MAR IF 200 by Rich-Mar Corp.
- MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM by Durtech System Corp.
- FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE by Dysphagia, LLC
- EMS 300 MUSCLE STIMULATORS by Paranamics, Inc.
- BTM-100 POWERED MUSCLE STIMULATOR (PROPOSED) by Bt Medical Co., Inc.
- H-WAVE by Electronic Waveform Laboratory, Inc.
- INTERFERENTIAL STIMULATOR, MODEL RTM1000 by Ryan Telemedicine
- MUSCLE STIMULATOR, ELECTRICAL by De Electronics
- MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR by MEDTRONIC VASCULAR, INC.