510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770635Substantially Equivalent

Protector, Heel & Elbow

Tecnol New Jersey Wound Care, Inc., Hammonton NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770635 is the FDA 510(k) clearance record for PROTECTOR, HEEL & ELBOW, a class I device, cleared for Tecnol New Jersey Wound Care, Inc. on under FDA product code FMP (Protector, Skin Pressure). FDA records list 35 510(k) clearances for Tecnol New Jersey Wound Care, Inc., from to . As of , FDA records show no recalls naming K770635.

Clearance record

Decision date
Received
(49 days to decision)
Product code
FMP Protector, Skin Pressure
Regulation
21 CFR 880.6450
Device class
Class I
Review panel
General Hospital
Applicant
Tecnol New Jersey Wound Care, Inc. 368 Fairview Ave., Hammonton NJ
Third party review
No

Clearances, product code FMP

Trailing 12 months

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

FDA records show no clearances under product code FMP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FMP, 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