Superior Bath, Model 6300

FDA 510(k) K012061 · Penner Manufacturing, Inc.

Substantially Equivalent

510(k) numberK012061

Submission

Device name
Superior Bath, Model 6300
Applicant
Penner Manufacturing, Inc.
Ohaha, NE, US
Received
July 2, 2001
Decision date
July 19, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
ILJ – Bath, Hydro-Massage
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5100
Specialty
Physical Medicine

Other 510(k)s with product code ILJ

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K110994Parker 500ILJ · Abbreviated Arjohuntleigh, Inc.07/06/2011SE
K082951Immersion HydrobathILJ · Traditional Arjo Hospital Equipment AB04/08/2009SE
K052479Mbath 1000 (60)ILJ · Traditional Enneking Medical, Inc.01/26/2006SE
K040772Pacific Recumbent Height-Adjustable Bath SystemILJ · Traditional Penner Manufacturing, Inc.04/05/2004SE
K012057Cascade Bath, Model 6900ILJ · Traditional Penner Manufacturing, Inc.07/19/2001SE
K001079Recumbent Bathing Systems, Rhapsody and PrimoILJ · Traditional Arjo, Inc.05/01/2000SE
K993872Vanna Bathing SystemILJ · Traditional Vancare, Inc.02/16/2000SE
K992779A-2000 Bathing Systems; Hydrosonic Bathin SystemILJ · Traditional Medi-Man Rehabilitation Products, Inc.01/13/2000SE
K991184Hydrotone-Thermal Capsule SystemILJ · Abbreviated Nats Corp.06/23/1999SE
K980909Vichy ShowerILJ · Traditional Bouvier Hydro, Inc.08/11/1998SE

More from Bouvier Hydro, Inc.

510(k)DeviceDecision
K040772Pacific Recumbent Height-Adjustable Bath SystemILJ · Traditional 04/05/2004SE
K012057Cascade Bath, Model 6900ILJ · Traditional 07/19/2001SE

Questions and answers

When was Superior Bath, Model 6300 cleared by the FDA?

Superior Bath, Model 6300 (K012061) received a 510(k) decision of Substantially Equivalent on July 19, 2001, 17 days after the submission was received.

What is the product code of K012061?

The FDA product code is ILJ – Bath, Hydro-Massage, a Class II (moderate risk) device regulated under 21 CFR 890.5100.