510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K920948Substantially Equivalent

Topical Sacral Hyperbaric Oxygen Chamber

Topox Therapeuutic Rentals, Inc., North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920948 is the FDA 510(k) clearance record for TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER, a class II device, cleared for Topox Therapeuutic Rentals, Inc. on under FDA product code KPJ (Chamber, Oxygen, Topical, Extremity). FDA records list one 510(k) clearance for Topox Therapeuutic Rentals, Inc. As of , FDA records show no recalls naming K920948.

Clearance record

Decision date
Received
(162 days to decision)
Product code
KPJ Chamber, Oxygen, Topical, Extremity
Regulation
21 CFR 878.5650
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Topox Therapeuutic Rentals, Inc. 45 W. St., North Attleboro MA
510(k) summary
Statement
Third party review
No

Clearances, product code KPJ

Trailing 12 months

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

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