510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K072882Substantially Equivalent

Pain Vision, Model Ps-2100

Osachi Co., Ltd., Las Vegas NV / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K072882 is the FDA 510(k) clearance record for PAIN VISION, MODEL PS-2100, a class I device, cleared for Osachi Co., Ltd. on under FDA product code LLN (Device, Vibration Threshold Measurement). FDA records list one 510(k) clearance for Osachi Co., Ltd. As of , FDA records show no recalls naming K072882.

Clearance record

Decision date
Received
(457 days to decision)
Product code
LLN Device, Vibration Threshold Measurement
Regulation
21 CFR 882.1200
Device class
Class I
Review panel
Neurology
Applicant
Osachi Co., Ltd. 3027 E. Sunset Rd., Suite 105, Las Vegas NV
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LLN

Trailing 12 months

FDA records hold no clearances under product code LLN in the trailing twelve months.

FDA records show no clearances under product code LLN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LLN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260