DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B


Device Classification Name

stimulator, nerve, transcutaneous, for pain relief

510(k) Number K030537
Device Name DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B
Applicant
WELL-LIFE HEALTHCARE, INC.
no. 5 alley 5 lane cheng hsing
chung ching rd., pei tun dist.
taichung, 

TW

Applicant Contact tony c. s. chang
Correspondent
WELL-LIFE HEALTHCARE, INC.
no. 5 alley 5 lane cheng hsing
chung ching rd., pei tun dist.
taichung, 

TW

Correspodent Contact tony c. s. chang
Regulation Number 882.5890
Classification Product Code
GZJ  
Subsequent Product Code
IPF  
Date Received 02/20/2003
Decision Date 03/20/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No