RHYTHM TOUCH Q 2-WAY— 510(k) K063743
Substantially EquivalentShockim Enterprises, Ltd.
FDA 510(k) clearance K063743 for RHYTHM TOUCH Q 2-WAY, Substantially Equivalent on 2007-05-24. Applicant: Shockim Enterprises, Ltd.. Device class: 2.
Clearance details
- Applicant
- Shockim Enterprises, Ltd.
- Product code
- Code NUH
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Laguna Niguel, CA, US
Recent devices under product code NUH
view all- 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)
- K253305 — TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
More clearances from Shockim Enterprises, Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.