Atlas FDA

CODETRON TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.

FDA 510(k) clearance K863469 · decided 1987-02-20

Clearance details

K-number
K863469
Device name
CODETRON TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.
Applicant
Cordis Corp.
Decision
Substantially Equivalent
Date received
1986-09-08
Decision date
1987-02-20
Days to decision
165 days
Clearance type
Traditional
Product code
GZJ
Device class
2
Regulation number
882.5890
Medical specialty
Neurology
Advisory committee
Neurology
Location
Miami, FL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Cordis Corp.

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
STIMPOD NMS460 Nerve Stimulator (K252712)Algiamed Technologies USA, Inc.2026-05-28
actiTENS mini (K252767)Sublimed2026-01-16
CP Relief Wand Rx - TENS/NMES (K252236)N & C Holdings, LLC2025-08-15
Unipro (K-UNIPRO-US) (K232441)Tenscare, Ltd.2024-08-30
TENSWave (K241228)Zynex Medical Officer2024-08-27
Electrical Neuromuscular Stimulator, Cure Trio (K233046)Oriental Inspiration Limited2024-04-19
Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) (K222879)Wuxi Jiajian Medical Instrument Co., Ltd.2023-01-24
iRelieve Microcurrent Pain Relief System (K212618)Fast Track Technologies, Inc.2022-09-14
StimOnTM Pain Relief System (GM2439) (K213802)Gimer Medical Co., Ltd.2022-08-26
Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) (K220578)Bozhou Rongjian Medical Appliance Co., Ltd.2022-05-25
TENS device-EmeTerm 2, Model: YF-ZTY-E2 (K220503)Wat Medical Technology, Inc.2022-04-23
Transcutaneous Electrical Nerve Stimulator (K202893)Wuxi Jiajian Medical Instrument Co., Ltd.2021-06-18

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S086)Cordis Corp.2014-10-10
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S082)Cordis Corp.2012-01-27
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S085)Cordis Corp.2012-01-26
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OVER-THE-WIRE DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTE (P020026/S059)Cordis Corp.2011-05-27
CYPHER SIROLIMUS CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER STENT (P020026/S083)Cordis Corp.2011-05-27
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER (P020026/S081)Cordis Corp.2011-03-03
CYPHER SIROLIMUS -ELUTING CORONARY STENT (4.0 MM) (P020026/S026)Cordis Corp.2011-02-22
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S078)Cordis Corp.2010-09-02