Balego TENS Digital Edition with Accessories for Pain Relief (OTC)— 510(k) K181207
Substantially EquivalentEveryway Medical Instruments Co., Ldt.
FDA 510(k) clearance K181207 for Balego TENS Digital Edition with Accessories for Pain Relief (OTC), Substantially Equivalent on 2018-06-06. Applicant: Everyway Medical Instruments Co., Ldt.. Device class: 2.
Clearance details
- Applicant
- Everyway Medical Instruments Co., Ldt.
- Product code
- Product code NUH
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- New Taipei City, TW
Recent devices under product code NUH
view all- K261574 — Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143)
- K261131 — Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J +6 more
- K260412 — TENS 7000 Rechargeable 4 Channel (TENS 7000H)
- K260425 — TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)
- K253896 — TENS/EMS device (GUSE01)
More clearances from Everyway Medical Instruments Co., Ldt.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.