510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963777Substantially Equivalent

Hyper Pulse Intermittent Topical Oxygen Chamber C-100, Cb-100

Stephenson Industries, Inc., Point Pleasant NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963777 is the FDA 510(k) clearance record for HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100, a class II device, cleared for Stephenson Industries, Inc. on under FDA product code KPJ (Chamber, Oxygen, Topical, Extremity). FDA records list 4 510(k) clearances for Stephenson Industries, Inc., from to . As of , FDA records show no recalls naming K963777.

Clearance record

Decision date
Received
(311 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
Stephenson Industries, Inc. 1648 Beaver Dam Rd., Point Pleasant NJ
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