SMP-PLUS,SX-PLUS,SX MODEL # 49XX SERIES 9 VOLT TENS DEVICE— 510(k) K982410
Substantially EquivalentRehabilicare, Inc.
FDA 510(k) clearance K982410 for SMP-PLUS,SX-PLUS,SX MODEL # 49XX SERIES 9 VOLT TENS DEVICE, Substantially Equivalent on 1998-11-06. Applicant: Rehabilicare, Inc.. Device class: 2.
Clearance details
- Applicant
- Rehabilicare, Inc.
- Product code
- Code GZJ
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New Brighton, MN, US
Recent devices under product code GZJ
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view all- K022405 — MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MIC
- K011017 — PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT
- K971542 — ORTHO DX NEUROMUSCULAR STIMULATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.